Cholangiocarcinoma (Bile Duct Cancer) trials

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Autologous T-cells Genetically Engineered to Express Receptors Reactive Against KRAS Mutations in Conjunction With a Vaccine Directed Against These Antigens in Participants With Metastatic Cancer is being studied. Conditions: Metastatic Solid Cancers, Colorectal Cancer, Breast Cancer +4 • Eligibility: * INCLUSION CRITERIA: * Participants with an appropriate HLA match for available Surgery Branch KRAS TCRs with evaluable metastatic solid cancer (e.g., gastrointestinal, genitourinary, breast, ovarian, non-small cell…. Goal: Background: Many cancer cells produce substances called antigens that are unique to each cancer. These antigens stimulate the body s immune responses. Phase/Status/Sponsor: Unknown phase; RECRUITING; National Cancer Institute (NCI).

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"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases". is being studied. Conditions: Chronic Liver Disease and Cirrhosis, Liver Cancer, Non-Alcoholic Fatty Liver Disease +4 • Eligibility: Inclusion Criteria: 1. Patients * diagnosed with chronic liver disease (viral or not) * diagnosed with at least one liver nodule for which a biopsy is planned as…. Goal: Development of preclinical translational models for chronic liver tumors and diseases study, such as spheroids cultured in autologous medium and murine xenograft models to test the efficacy of new therapeutic strategies. Phase/Status/Sponsor: Unknown phase; RECRUITING; Institut National de la Santé Et de la Recherche Médicale, France.

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The Sarah Nanotechnology System for Treatment of Advanced Metastatic Solid Tumors Using Hyperthermia. is being studied. Conditions: Metastatic Solid Tumors, Stage 4 Cancer • Eligibility: Inclusion Criteria: 1. Life expectancy of at least 90 days. 2. Histologically confirmed advanced metastatic solid tumors located between the thoracic inlet and the pelvic floor, that have…. Goal: This is a sequential, dose-escalation, non-randomized, prospective, early feasibility trial. The goal of this clinical trial is to gather information on the safety and the recommended dose of the Sarah Nanotechnology System. Phase/Status/Sponsor: Unknown phase; RECRUITING; New Phase Ltd..

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PD-1 Antibody Plus GEMOX as Postoperative Adjuvant Therapy in Perihilar Cholangiocarcinoma is being studied. Conditions: Perihilar Cholangiocarcinoma • Eligibility: Inclusion Criteria: 1. The patient must sign an informed consent form; 2. Age 18-75 years old, both male and female; 3. ECOG performance status score (PS score) 0…. Goal: This is an open-label,single center,non-randomized,single arm exploratory study. The objective of this study is to evaluate the efficacy and safety of PD-1 antibody plus GEMOX as postoperative adjuvant therapy in perihilar cholangiocarcinoma with positively metastatic lymph nodes. Phase/Status/Sponsor: Unknown phase; RECRUITING; Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.

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Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma is being studied. Conditions: Mesothelioma, Thymoma, Pancreatic Neoplasms +2 • Eligibility: * INCLUSION CRITERIA: * All participants greater than or equal to 2 years of age with malignant mesothelioma. * All participants greater than or equal to18 years of…. Goal: Background: * Malignant mesothelioma is a malignancy arising from the mesothelial cells of the pleura, peritoneum, pericardium, or tunica vaginalis. * Mesothelioma accounts for 0.10% of deaths annually in the United States. Phase/Status/Sponsor: Unknown phase; RECRUITING; National Cancer Institute (NCI).

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This trial tests adding PDS01ADC to a liver-directed chemotherapy approach (HAIP with FUDR and dexamethasone) plus standard systemic chemotherapy for certain liver cancers. It is for adults 18 and older with unresectable cancer confined to or dominant in the liver, specifically metastatic colorectal cancer to the liver, intrahepatic cholangiocarcinoma, or adrenocortical carcinoma with liver metastases. The study aims to learn the objective response rate, i.e., how often tumors shrink, with this combination therapy. Eligible participants must have had first-line systemic chemotherapy and will receive HAIP-delivered chemotherapy, PDS01ADC injections every four weeks, and ongoing systemic chemotherapy. Exclusions include active autoimmune disease (with some steroid replacement exceptions), active hepatitis B or C infection, significant cardiovascular disease, prior FUDR exposure, and other factors that could confound results.

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This trial tests nanvuranlat in adults with biliary tract cancer to find a recommended dose regimen (Part A) and to study its effect on overall survival compared with the physician’s best choice (Part B). Participants are 18 years or older with advanced, metastatic, or unresectable BTC who have received one prior platinum-based therapy. Treatments are given every two weeks with safety checks, tumor imaging, and exploratory tests to understand how the drug works. Key exclusions include active CNS metastases, significant cardiovascular disease, HIV not on therapy, active HBV or HCV infection, and pregnancy.

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- This study tests precision-based immunotherapy approaches for primary liver cancer (hepatocellular carcinoma and cholangiocarcinoma) and aims to build a biospecimen repository to study the biology of the cancer and how patients respond to treatment. - It will enroll adults 18 and older with liver cancer who are receiving or planning to receive immunotherapy, and will collect medical records, imaging, tumor tissue, and samples such as blood, urine, and stool over time. - Researchers will perform a wide range of analyses (genomics, epigenetics, metabolomics, microbiome, and immune monitoring) to identify factors that predict response or resistance to immunotherapy and to understand disease progression. - HIV infection is an exclusion criterion, and the study is currently recruiting.

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- This trial tests whether adding durvalumab to the chemotherapy drugs gemcitabine and cisplatin given before surgery helps treat high-risk, resectable intrahepatic cholangiocarcinoma (liver cancer). - It is for adults who are considered candidates for curative surgery. - Researchers want to learn how many patients can complete the pre-surgery therapy and then have the tumor completely removed, as well as rates of major tumor response and overall survival after treatment. - Key exclusions include pregnancy, active autoimmune diseases, active infections (including hepatitis B or C), recent major surgery or current immunosuppressive therapy, and other conditions that could affect safety or results.

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Biobank for Cholestatic Liver Diseases. is being studied. Conditions: Primary Sclerosing Cholangitis, Primary Biliary Cirrhosis, Cholangiocarcinoma +1 • Eligibility: Inclusion Criteria: PSC * Patients diagnosed with PSC and who are between the age of 18 and 85 at time of enrollment in the study. * The diagnosis…. Goal: This study is a biobank of specimens and clinical data for use in current and future research to better understand the cholestatic liver diseases primary biliary cirrhosis/cholangitis (PBC) and primary sclerosing cholangitis (PSC). Phase/Status/Sponsor: Unknown phase; RECRUITING; Mayo Clinic.

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SynKIR-110 for Mesothelin Expressing Ovarian Cancer, Cholangiocarcinoma or Mesothelioma is being studied. Conditions: Ovarian Cancer, Cholangiocarcinoma Recurrent, Mesothelioma, Malignant • Eligibility: Inclusion Criteria: * Pathologically confirmed recurrent or relapsed advanced ovarian cancer, primary peritoneal cancer, fallopian tube cancer, cholangiocarcinoma, or epithelial mesothelioma (pleural or peritoneal) after at least 1…. Goal: This first-in-human (FIH) trial is designed to assess the safety, feasibility, and potential activity of a single intravenous (IV) dose of SynKIR-110 administered to subjects with mesothelin-expressing advanced ovarian cancer, mesothelioma, and cholangiocarcinoma. Phase/Status/Sponsor: Unknown phase; RECRUITING; Verismo Therapeutics.

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This is a phase I dose-escalation trial testing AU409, an RNA transcription modulator, to find the safest and recommended dose and to study its safety in adults with advanced liver cancers or solid tumors that have spread to the liver. Eligible participants are adults 18 and older with an advanced solid tumor that has exhausted standard treatments (or no good options), especially with liver-dominant disease or primary liver cancer; exclusions include untreated brain metastases, serious heart problems, active hepatitis B, pregnancy, or recent anticancer therapy. The study aims to determine the maximum tolerated dose and the recommended phase II dose and to assess safety and how AU409 behaves in the body. It will also look for early signs of anti-tumor activity on imaging and may collect tumor tissue and blood samples for analysis.

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HAI-Floxuridine, or SIRT, Combined With Gemox For Patients With Intra-Hepatic Cholangiocarcinoma Not Amenable to Resection (TOMCAT) is being studied. Conditions: Intrahepatic Cholangiocarcinoma, Chemotherapy Effect • Eligibility: Inclusion Criteria: 1. Intra-hepatic cholangiocarcinoma. Diagnosis confirmed by biopsy, cytology or previous resection. 2. Not amenable for upfront resection. Defined as: 1. A tumour that is technically not…. Goal: Patients with intrahepatic cholangiocarcinoma (IHC) have relatively aggressive tumors, and the prognosis for most of these patients is dismal. Surgery is the only option that can offer potential cure, but only an estimated 20-25 % are amenable to resection. Phase/Status/Sponsor: Unknown phase; RECRUITING; Oslo University Hospital.

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- This study tests BOLD-100 given with the chemotherapy FOLFOX in adults with advanced gastrointestinal cancers (such as colorectal, pancreatic, gastric cancers, and cholangiocarcinoma) to assess safety and tolerability, using a dose-escalation phase followed by expansion. - In the colorectal cancer arm (Arm VII), eligible patients who are oxaliplatin-naïve and have had only one prior metastatic therapy will be randomized to three groups: BOLD-100 at 500 mg/m2 with FOLFOX, BOLD-100 at 625 mg/m2 with FOLFOX, or FOLFOX alone, with quality-of-life assessments. - The trial aims to learn whether adding BOLD-100 provides anti-tumor activity and how it affects patients’ quality of life, while establishing safe dose levels. - Key exclusions include neuropathy greater than grade 2, CNS metastases, active HIV on ART, DPD deficiency, prior exposure to BOLD-100 (for Arm VII), MSI-H tumors, and recent major treatments or other serious conditions.

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DESTINY-PANTUMOUR04 is being studied. Conditions: Adenocarcinoma (NOS), Anal Cancer, Bladder Cancer +24 • Eligibility: Inclusion Criteria: 1. Adults aged ≥18 years 2. Patients with locally advanced, unresectable, or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment for metastatic…. Goal: This study will evaluate the effectiveness of T-DXd in patients with HER2-positive (IHC 3+) locally advanced, unresectable, or metastatic solid tumors who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options in a real-world setting in the US Phase/Status/Sponsor: Unknown phase; RECRUITING; AstraZeneca.

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Outcomes After Laparoscopic Versus Open Pancreaticoduodenectomy is being studied. Conditions: Pancreatic Ductal Adenocarcinoma, Ampullary Carcinoma, Distal Cholangiocarcinoma +2 • Eligibility: Inclusion Criteria: * Age ≥18 years. * Histologically confirmed or clinically suspected lesions of: Pancreatic head adenocarcinoma, Ampullary carcinoma, Distal cholangiocarcinoma, Duodenal adenocarcinoma, Pancreatic neuroendocrine tumors, or Intraductal…. Goal: This is a monocentric, prospective, randomized controlled trial comparing the safety and efficacy of laparoscopic pancreaticoduodenectomy (LPD) versus open pancreaticoduodenectomy (OPD). The study aims to determine the morbimortality of the laparoscopic approach compared to the gold standard open approach in adult patients with pancreatic or periampullary lesions. Phase/Status/Sponsor: Unknown phase; RECRUITING; Minia University.

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A Study of LY4337713 in Participants With FAP-Positive Solid Tumors is being studied. Conditions: Ovarian Neoplasms, Breast Neoplasms, Pancreatic Intraductal Neoplasms +4 • Eligibility: Inclusion Criteria: * Must have clinical or imaging evidence of fibroblast activation protein (FAP) expression per local assessment * Must have histologically or cytologically confirmed diagnosis of one…. Goal: This is a study of LY4337713 in participants with certain types of cancer that is advanced or has spread. Participants must have cancer with high levels of a protein called fibroblast activation protein (FAP). Phase/Status/Sponsor: Unknown phase; RECRUITING; Eli Lilly and Company.

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- This trial compares rilvegostomig plus gemcitabine and cisplatin versus durvalumab plus gemcitabine and cisplatin as first-line treatment for advanced biliary tract cancer. - It is for adults with unresectable locally advanced or metastatic BTC, including intrahepatic or extra-hepatic cholangiocarcinoma and gallbladder cancer, who have not yet received systemic therapy for advanced disease and have measurable disease with good performance status. - The study aims to learn which regimen provides better efficacy and acceptable safety when used at the start of treatment. - Key exclusions include ampullary cancer, prior systemic therapy for unresectable or metastatic BTC, prior exposure to immune-targeting therapies, active autoimmune disease requiring steroids, and certain interstitial lung disease or serious skin conditions. - Sponsor: AstraZeneca; Status: Recruiting; Phase: Unknown.

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Summary not available yet.

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Cabozantinib Plus Durvalumab With or Without Tremelimumab in Patients With Gastroesophageal Cancer and Other Gastrointestinal Malignancies is being studied. Conditions: Gastric Cancer, Esophageal Adenocarcinoma, Hepatocellular Carcinoma +1 • Eligibility: Inclusion Criteria: 1. Age ≥ 18 years 2. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 3. Histologically confirmed diagnosis of any of the following: • Gastric or…. Goal: The investigators propose to evaluate the safety of drug combinations in patients with advanced gastroesophageal cancer and other gastrointestinal (GI) malignancies. Finding effective novel therapies for patients with advanced gastric cancer and other GI malignancies is an area of great unmet need. Phase/Status/Sponsor: Unknown phase; RECRUITING; Anwaar Saeed.

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Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer is being studied. Conditions: Biliary Tract Cancer • Eligibility: Inclusion Criteria 1. Histologically- or cytologically-confirmed Biliary Tract Cancer (BTC), including Gallbladder Cancer (GBC), Intrahepatic Cholangiocarcinoma (ICC), or Extrahepatic Cholangiocarcinoma (ECC). 2. Locally advanced unresectable or metastatic BTC…. Goal: The purpose of this study is to evaluate the efficacy and safety of Zanidatamab plus CisGem (Cisplatin and Gemcitabine) with or without the addition of a programmed death protein 1/ligand-1 (PD-1/L1) inhibitor (physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations) as first line of treatment for participants with human epidermal growth factor receptor 2 (HER2)-positive biliary tract cancer. Phase/Status/Sponsor: Unknown phase; RECRUITING; Jazz Pharmaceuticals.

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Institutional Registry of Rare Diseases is being studied. Conditions: Rare Diseases, Amyloidosis, Sarcoidosis +23 • Eligibility: Inclusion Criteria: * Clinical and/or molecular diagnosis of any of the following rare diseases: Amyloidosis, Sarcoidosis, Phacomatosis, Pheochromocytoma, Paraganglioma, Von Hippel-Lindau Disease, Immunoglobulin G4-Related Disease, Demyelinating Diseases, Inborn…. Goal: The goal of this observational study is to create a single macro registry system with data collection on common clinical features, grouping the different rare diseases (RD). Moreover, the specific goals are to generate an alert system for possible cases of RD with data from the electronic medical record, to describe the occurrence of RD in the evaluated population, to characterize the population, to describe patterns of diagnosis and treatment of RD present at the time, and to explore patient-reported outcomes. Phase/Status/Sponsor: Unknown phase; RECRUITING; Hospital Italiano de Buenos Aires.

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This trial tests Gallium-68 FAPI PET/CT to see if it improves detection, staging, and restaging of biliary tract cancers compared with the standard FDG PET/CT. It is for adults 18 and older with suspected or confirmed biliary cancers, including gallbladder cancer, cholangiocarcinoma, or suspected recurrence after treatment. The study will assess how well FAPI detects primary tumors, lymph node involvement, and metastases and whether it changes clinical decisions or reduces the need for invasive procedures. Participants must give informed consent, and those with a concurrent malignancy are excluded.

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Target-specific immunoPET Imaging of Digestive System Carcinoma is being studied. Conditions: Malignancy, Digestive Cancer, Digestive System Neoplasm +12 • Eligibility: Inclusion Criteria: 1. Aged 18-75 years old and of either sex； 2. Histologically confirmed diagnosis of digestive system carcinoma or suspected digestive system carcinoma by diagnostic imaging; 3.…. Goal: The aim of this study is to establish and optimize the target-specific PET/CT imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agents in digestive system malignant tumors will be evaluated. Phase/Status/Sponsor: Unknown phase; RECRUITING; RenJi Hospital.

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Collection of Blood From Patients With Cancer is being studied. Conditions: Prostate Cancer, Breast Cancer, Colon Cancer +2 • Eligibility: * INCLUSION CRITERIA: Patients with a known or suspected malignancy and healthy volunteers 18 years of age and older are eligible. Performance status of ECOG 0, 1, 2,…. Goal: This study will collect blood from patients with cancer to study the level of cells which decrease the immune response (suppressor cells) before and after chemotherapy. Patients 18 years of age and older with cancer may participate. Phase/Status/Sponsor: Unknown phase; RECRUITING; National Cancer Institute (NCI).

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- This trial tests PULSAR together with dual immune checkpoint inhibitors (PD-1 and CTLA-4 antibodies) and gemcitabine/cisplatin (GC) chemotherapy in people with locally advanced or metastatic cholangiocarcinoma. - It is for adults aged 18 to 75 who have at least one measurable tumor and can receive radiotherapy, immunotherapy, and chemotherapy. - The study aims to determine how well the combination works and how safe it is, and to learn about its effects on the tumor environment and the body's immune response. - Key exclusions include prior anti-PD-1/PD-L1 therapy, active autoimmune diseases (with some exceptions), active infections or HIV/HCV, and having previously received systemic therapy for cholangiocarcinoma. - The trial is currently recruiting.

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The trial tests whether proteomic profiling of bile can be used to diagnose cholangiocarcinoma. It will compare bile-based proteomic results with standard histology to see how often they agree. It is for adults 18 and older who have bile duct narrowing and need diagnostic endoscopy or imaging with tissue sampling. Pregnant women and people under legal protection are excluded, and participants must provide oral consent.

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This trial tests the drug tivozanib for biliary tract cancers (cholangiocarcinoma and gallbladder cancer) in adults who have already had chemotherapy, to find the safest and most effective dose and to learn its overall response rate. It is open-label, non-randomized, and carried out at a single center, using 28-day treatment cycles (3 weeks on, 1 week off) with efficacy checked every 8 weeks. Eligible participants are adults 18 or older with biliary tract cancer not removable by surgery who have had prior first-line chemotherapy and have adequate organ function. Key exclusions include prior tivozanib use, pregnancy, and significant cardiovascular disease or uncontrolled hypertension.

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Phase II Study Evaluating Ivosidenib Maintenance After SOC Adjuvant Chemotherapy in Curative mIDH1 Cholangiocarcinoma is being studied. Conditions: Cholangiocarcinoma, IDH Mutation • Eligibility: Inclusion Criteria: 1. Patient\* provides signed informed consent. 2. Patient is ≥ 18 years at the time of given informed consent. 3. Patient has histologically documented curatively resected…. Goal: This study trial is a prospective, multicentre, exploratory, single-arm, open-label phase II study to evaluat ivosidenib maintenance after SOC adjuvant chemotherapy in curative mIDH1 cholangiocarcinoma Phase/Status/Sponsor: Unknown phase; RECRUITING; Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest.

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This trial tests a three‑drug combo—Apatinib, Adebrelimab, and GEMOX chemotherapy—for adults with unresectable intrahepatic cholangiocarcinoma (ICC). It aims to see if this regimen can achieve more tumor shrinkage and longer survival, while keeping an eye on safety, compared with historical data for chemotherapy alone. Eligible participants are adults 18–75 with confirmed ICC that cannot be removed by surgery or has progressed after prior treatment, and who have good liver function and performance status. Up to 38 people will be enrolled at multiple hospitals; key exclusions include prior immune checkpoint inhibitor treatment, having another active cancer, and conditions like significant ascites or uncontrolled medical issues.

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[212Pb]VMT-Alpha-NET in Metastatic or Inoperable Somatostatin-Receptor Positive Gastrointestinal Neuroendocrine Tumors, Pheochromocytoma/Paragangliomas, Small Cell Lung, Renal Cell, and Head and Neck Cancers is being studied. Conditions: Head and Neck Tumors, Kidney Cancers, Small Cell Lung Cancers +3 • Eligibility: * INCLUSION CRITERIA: * Participants must have histopathologically confirmed gastrointestinal neuroendocrine tumors (GI NET), pheochromocytoma/paraganglioma (PPGL), small cell lung cancers (SCLC), kidney cancers (KC), or Head \& Neck…. Goal: Background: Some cancers have high levels of proteins called somatostatin receptors (SSTRs) on the surface of the tumors. These tumors can be in the lung, head and neck, digestive tract, kidneys, and in or near the adrenal glands. Phase/Status/Sponsor: Unknown phase; RECRUITING; National Cancer Institute (NCI).

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This study tests GV20-0251 to see if it is safe in adults with advanced or refractory solid tumors. It is a single-center, single-arm early-stage trial at West China Hospital. It uses a 3+3 dose-escalation design, starting with 10 mg/kg and 20 mg/kg given every three weeks, to find a tolerable dose and watch for dose-limiting toxicities. The trial covers multiple solid tumor types to learn about safety and dosing across indications. Key exclusions include active infections, certain heart problems or QT prolongation, autoimmune disease needing immunosuppressive therapy, HIV/HBV/HCV infections, pregnancy, and recent major surgery.

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A Phase II Study of Pemigatinib Plus Durvalumab in Previously Treated Advanced Intrahepatic Cholangiocarcinoma Patients With FGFR-2 Fusion or Rearrangement is being studied. Conditions: Intrahepatic Cholangiocarcinoma, FGFR2 Gene Rearrangement, FGFR2 Gene Mutation • Eligibility: Inclusion Criteria: 1. Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent…. Goal: This is a single arm phase II study of pemigatinib and durvalumab combination in patients with FGFR-2 fusion or rearrangement positive intrahepatic cholangiocarcinoma. Each cycle will be 3 weeks. Phase/Status/Sponsor: Unknown phase; RECRUITING; Mehmet Akce.

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- This multicenter, open-label, single-group trial tests photodynamic therapy using Cosiporfin Sodium together with gemcitabine and cisplatin (GC) for people with locally advanced or recurrent metastatic extrahepatic cholangiocarcinoma that cannot be operated on. - It aims to preliminarily measure efficacy, focusing on the 6-month overall survival rate, and to assess safety and tolerability of the PDT plus GC treatment in patients with biliary obstruction. - Eligible participants are adults with histologically confirmed disease, inoperable or unwilling to have surgery, with biliary obstruction and at least one measurable lesion outside the bile ducts, plus good performance status and adequate organ function. - Key exclusions include ampullary cancer, brain metastases, major liver tumor burden (>50%), prior exposure to photosensitizers or PDT, prior systemic therapy in the recurrent/metastatic setting, unremovable biliary stents, active infections, and other conditions that could interfere with treatment.

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Study of Gemcitabine, Cisplatin, AB680 and AB122 During First Line Treatment of Advanced Biliary Tract Cancers (QUIC) is being studied. Conditions: Biliary Tract Carcinoma, Cholangiocarcinoma, Bile Duct Cancer • Eligibility: Inclusion Criteria: 1. Patients with cytologically or histologically confirmed BTC by AJCC version 8. 2. Patients must have late stage (locally advanced, recurrent or metastatic) BTC. Patients must…. Goal: This is a phase 2 study of gemcitabine, cisplatin, zimberelimab (AB122) and quemliclustat (AB680) in subjects with untreated advanced biliary tract cancers (BTC). The study will include a safety run-in involving 6 study participants. Phase/Status/Sponsor: Unknown phase; RECRUITING; Nataliya Uboha.

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Impact of Emotional Disorders on Response to Immune Checkpoint Inhibitor Therapy in Liver Cancer is being studied. Conditions: Liver Cancer, Emotional Disorder • Eligibility: Inclusion Criteria: * Age between 18 and 75 years, inclusive, regardless of gender. * Presence of at least one radiologically measurable lesion according to the Response Evaluation Criteria…. Goal: Hepatocellular carcinoma (HCC) carries a poor prognosis, with limited efficacy from current therapies including immune checkpoint inhibitors (ICIs). Concurrently, emotional distress (ED) is highly prevalent in cancer patients and is implicated in tumor progression via neuroendocrine-immune axis dysregulation (e.g., HPA axis activation, immunosuppressive TME). Phase/Status/Sponsor: Unknown phase; RECRUITING; Tongji Hospital.

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This Mayo Clinic-sponsored trial, currently recruiting, tests delivering cancer treatment at home versus in the clinic for adults with advanced cancer who are already receiving standard therapy. It aims to learn how the home-based approach affects patient experiences, preferences, comfort with home infusions, and overall quality of life compared with usual clinic care. The study also looks at safety of home administration with remote monitoring, and outcomes like emergency room visits, hospitalizations, and overall survival. Eligible participants are adults with various cancer types on eligible regimens, but those who need 24/7 assistance with daily activities, are currently inpatient, or have uncontrolled illness may be excluded.

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This study tests whether ivonescimab is more effective than the standard second‑line chemotherapy FOLFOX for adults with advanced biliary tract cancer who progressed after first‑line treatment and who participated in SAFIR-ABC10. Participants are randomized 2:1 to receive ivonescimab every 3 weeks or FOLFOX, with the ivonescimab arm limited to up to 34 cycles. Treatments continue until disease progression or until the study limits are reached, and tumor responses are checked by imaging roughly every 6 weeks using RECIST v1.1. Key exclusions include contraindication to ivonescimab, unresolved toxicities from prior therapy, and conditions such as active HIV or TB, active autoimmune disease requiring systemic treatment, pregnancy, or recent major surgery.

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Liquid Biopsy Using Exosomal miRNA Enables Risk Stratification of Potential Metastasis in Patients With Intrahepatic Cholangiocarcinoma. is being studied. Conditions: Intrahepatic Cholangiocarcinoma (Icc) • Eligibility: Inclusion Criteria: * Histologically confirmed ICC (clinical stage I-III). * Undergoing curative-intent hepatectomy. * Availability of preoperative pasma or serum sample (≥200 µL). * Standard staging imaging completed…. Goal: Occult metastasis at the time of surgery is a major driver of poor outcomes in intrahepatic cholangiocarcinoma (ICC), yet reliable preoperative biomarkers to identify such patients are lacking. The EXOMIC study aims to develop and validate a circulating exosomal microRNA (exo-miRNA)-based liquid biopsy assay to detect occult metastasis preoperatively in patients with resectable ICC. Phase/Status/Sponsor: Unknown phase; RECRUITING; City of Hope Medical Center.

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Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes is being studied. Conditions: Cancer Pain, Visceral Pain, Gastrointestinal Neoplasms +76 • Eligibility: Inclusion Criteria: * Have a primary malignancy of the biliary tract, colon, liver, pancreas, peritoneum, rectum, small intestine, or stomach, with no plan for resection during the study…. Goal: Patients with digestive tract malignancy often experience severe and unremitting abdominal pain that negatively affects physical, emotional, and social function, as well as health related quality of life (HRQOL). Therapeutic virtual reality (VR) has emerged as a promising and evidence-based treatment modality for cancer pain. Phase/Status/Sponsor: Unknown phase; RECRUITING; Cedars-Sinai Medical Center.

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SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and Registry is being studied. Conditions: Cancer, Metastatic, Cancer, Cancer of Pancreas +40 • Eligibility: Inclusion Criteria: * Pts with solid and hematological malignancies; * Pts cancer-related biomarkers, gene variants, fusion and rearrangements (by immunohistochemistry, PCR, FISH or NGS): PD-L1, MSI (MMR), Claudin18.2,…. Goal: International registry for cancer patients evaluating the feasibility and clinical utility of an Artificial Intelligence-based precision oncology clinical trial matching tool, powered by a virtual tumor boards (VTB) program, and its clinical impact on pts with advanced cancer to facilitate clinical trial enrollment (CTE), as well as the financial impact, and potential outcomes of the intervention. Phase/Status/Sponsor: Unknown phase; RECRUITING; Massive Bio, Inc..

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- The trial tests whether contrast-enhanced ultrasound (CEUS) can be used to evaluate how hepatocellular carcinoma (HCC) responds after transarterial radioembolization (TARE). - It is for adults with treatment-naïve HCC who are scheduled to undergo TARE. - The study will compare CEUS results with standard CT or MRI at about 1–2 months and 4–6 months post-TARE to see if CEUS can detect viable tumor earlier. - About 30 patients will be enrolled over 18 months across Jefferson Health sites, with at least 6 months of follow-up. - Exclusion criteria include medical instability or serious illness and known sensitivities to the ultrasound contrast agents Lumason or Sonazoid.

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- This randomized, multicenter trial tests UI-EWD (Nexpowder) hemostatic powder as the initial treatment, compared to conventional endoscopic therapies for nonvariceal upper GI bleeding. - It is for adults 22 years and older who have acute overt upper GI bleeding seen on endoscopy from ulcers with active bleeding or a visible vessel, tumors with bleeding, Dieulafoy lesions, or Mallory-Weiss tears. - The study aims to determine whether UI-EWD is noninferior to traditional therapy in stopping bleeding and reducing rebleeding when used first. - Key exclusions include pregnancy or nursing, inability to consent, recent endoscopic hemostatic treatment within 30 days, triple antithrombotic therapy, very low platelet count (<50 x 10^9/L), high INR (>3.5), and endoscopy not performed within 36 hours.

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This study tests the molecular and genetic basis of pediatric liver cancer by analyzing tumor tissue, blood, and saliva from affected children and their biological parents and siblings. It is for children under 21 who have had a liver tumor (benign or malignant) and their families. Researchers aim to learn how gene defects and gene function influence how these cancers develop and behave, to improve classification and future treatments. Exclusions include no prior or current treatment for a childhood liver tumor, and non-biological guardians or non-biological siblings.

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A Multilevel Approach to Connecting Underrepresented Populations to Clinical Trials is being studied. Conditions: Cancer • Eligibility: Inclusion Criteria: * An adult 18 to 100 years of age, * Able to read English or Spanish at least an eighth-grade level, * From a racial/ethnic background…. Goal: The purpose of this study is to pilot test and evaluate an existing tailored ALEX (Agent Leveraging Empathy for eXams) Research Portal to navigate Black and Hispanic adult cancer patients and their family members through referral to cancer clinical trials. Phase/Status/Sponsor: Unknown phase; RECRUITING; University of Florida.

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- The study tests a 3D biliary tract reconstruction tool and an AI algorithm to help endoscopists perform ERCP by creating 3D models from MRCP and CT scans. - It is for adults with biliary strictures who are treated with ERCP at Saint Antoine Hospital or Henri Mondor Hospital. - The study is retrospective and uses imaging data collected during routine care to develop and validate the software. - The goal is to see if the 3D models improve visualization and navigation during ERCP, with performance assessed by image-quality metrics and localization error, and without changing patient management. - Exclusion: patients who do not consent to reuse their data for research.

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A Clinical Study to Evaluate the Efficacy and Safety of Hyoscine Butylbromide Capsules for Preoperative Preparation in Painless Gastrointestinal Endoscopy Procedures is being studied. Conditions: Painless Gastrointestinal Endoscopy • Eligibility: Inclusion Criteria: * Age ≥18 years and ≤75 years, regardless of sex; * Patients scheduled to undergo painless gastrointestinal endoscopy examination or endoscopic surgery, which must include upper…. Goal: Gastrointestinal endoscopy procedures, including upper gastrointestinal endoscopy and colorectal endoscopy, represent a fundamental and important method for examining and managing digestive tract diseases, with both diagnostic and therapeutic applications. They are also utilized as effective tools for surveillance of gastrointestinal tumors. Phase/Status/Sponsor: Unknown phase; NOT_YET_RECRUITING; Shanghai Jiao Tong University School of Medicine.

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- The study tests LY4066434, a pan-KRAS inhibitor, in people with KRAS-mutant solid tumors. - It includes patients whose tumors have specific KRAS mutations (G12C, G12D, G12V, G12A, G12S, or G13D) and who have locally advanced, unresectable, or metastatic cancer with measurable disease. - The trial will evaluate LY4066434 alone or with other treatments to see if it is safe and tolerable, using two parts: monotherapy dose escalation and dose optimization, over up to about 5 years. - Key exclusions include active CNS metastases, significant cardiovascular disease, active hepatitis B or C or untreated HIV, other active cancers, and uncontrolled infections.

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- The trial tests a new PET imaging tracer called 89Zr-labeled girentuximab (TLX250) that targets CAIX to visualize tumors. - It includes adults with hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma (ICC), or gastro-entero-pancreatic neuroendocrine neoplasms (GEP-NENs), with separate baskets for these groups. - The study aims to learn how well this tracer images CAIX-expressing tumors and whether it could help guide precision medicine for these cancers. - Key exclusions include allergy to zirconium-89, recent cancer treatments or major surgery, uncontrolled brain metastases or severe heart disease, pregnancy, or life expectancy under 4 months. - The study is sponsored by Nantes University Hospital and is currently recruiting.

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Gemcitabine and Oxaliplatin Chemotherapy With or Without a Floxuridine and Dexamethasone Pump in People With Cholangiocarcinoma That Cannot Be Removed With Surgery is being studied. Conditions: Intrahepatic Cholangiocarcinoma • Eligibility: Inclusion Criteria: * Age ≥18 years * ECOG 0-1 * Histologically confirmed intrahepatic cholangiocarcinoma (also variously reported as peripheral cholangiocarcinoma, cholangiolar carcinoma or cholangiocellular carcinoma) (IHC). Confirmation of…. Goal: This study will compare the safety and effects of HAI floxuridine and dexamethasone combined with the standard chemotherapy drugs gemcitabine and oxaliplatin (GemOx) with those of GemOx alone in people with untreated cholangiocarcinoma that cannot be removed with surgery. The researchers want to find out whether the study treatment works better than the standard chemotherapy to delay progression of disease. Phase/Status/Sponsor: Unknown phase; RECRUITING; Memorial Sloan Kettering Cancer Center.

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- This is a single-arm trial testing whether adding pembrolizumab to the standard chemotherapy drugs gemcitabine and cisplatin given before surgery improves outcomes for potentially resectable intrahepatic cholangiocarcinoma. - It targets adults with high-risk disease confined to the liver, bile ducts, and nearby lymph nodes who are planned for curative surgery. - The study aims to see if pembrolizumab improves recurrence-free survival after surgery and increases major pathologic response, while also evaluating safety and overall survival, plus various biomarker and immune studies. - Key exclusions include prior anti-PD-1/PD-L1 therapy, prior systemic therapy for ICC, active CNS metastases, active infection or autoimmune disease requiring systemic treatment, pregnancy or lack of contraception, and certain hepatitis B/C or HIV conditions.

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- This early-phase trial tests a treatment for unresectable liver cancer using a patient’s own dendritic cells plus the Prevnar vaccine, given with immune checkpoint inhibitors after high-dose external beam radiotherapy. - It includes adults with hepatocellular carcinoma or intrahepatic cholangiocarcinoma that cannot be removed and have been treated with EBRT, with dendritic cells injected into the tumor and vaccines given alongside atezolizumab plus bevacizumab or atezolizumab plus tiragolumab. - The study aims to evaluate safety and tolerability and to estimate progression-free survival and other outcomes to see if this approach can stimulate the immune system and slow the cancer, compared with historical data. - Key exclusions include pregnancy or breastfeeding, immunocompromised status (including HIV), active infection or uncontrolled illness, autoimmune disease (with some exceptions), inability to stop anticoagulants for injections, and advanced liver disease (Child-Pugh B/C) or prior immune-modulating therapy.

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Improving Comprehensive Care of Cancer Patients is being studied. Conditions: Breast Cancer, Gastrointestinal Cancer, Hematologic Cancer • Eligibility: Inclusion Criteria: * For patients: 1) new diagnosis or within three months of treatment initiation for early-stage breast (I-IIIB), GI (Stage I-III), or hematologic (Stage I-III) cancer 2)…. Goal: Cancer survivors have unique healthcare needs, including managing serious late effects, ongoing surveillance, lifestyle modifications to reduce second cancer risk, and psychosocial support. Nearly 70% of survivors have at least one comorbid chronic condition in addition to cancer, which complicates the delivery of quality cancer care. Phase/Status/Sponsor: Unknown phase; RECRUITING; Baylor College of Medicine.

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- This multicenter, prospective study tests whether performing a liver transplant after neoadjuvant radiotherapy and chemotherapy can help people with unresectable hilar cholangiocarcinoma. - It includes adults 70 or younger with tumors up to 3 cm at the hilum and no lymph node or distant metastases. - The study will measure overall survival at 1, 3, and 5 years after transplant, plus recurrence-free survival, overall intention-to-treat survival, and how many eligible patients ultimately receive a transplant. - Key exclusions include prior chemotherapy or radiotherapy outside the protocol, existing liver, extrahepatic, or lymph node metastases, prior or concurrent cancers different from certain treated low-risk cancers, and uncontrolled infection.

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Prospective Data Registry and Quality of Life Assessment of Patients Undergoing Radiotherapy With the RefleXion Medical Radiotherapy System is being studied. Conditions: Cancer, Cancer Central Nervous System, Cancer Thoracic +5 • Eligibility: Inclusion Criteria: * Able to comprehend and be willing to sign an informed consent form (ICF). * Diagnosis of local, loco-regionally advanced, or metastatic malignancy for whom radiotherapy…. Goal: The purpose of this prospective cohort study is to assess clinical and quality of life measures as well as to define the severity of adverse effects for the use of the RefleXion system to deliver intensity-modulated radiotherapy (IMRT), stereotactic body radiotherapy (SBRT), or SCINTIX Biology-guided radiotherapy (BgRT) in standard of care (SOC) use in the treatment of local,loco-regionally advanced, and oligometastatic malignancies. In addition, patient costs and charges will be analyzed to quantify the health economic impact of this modality. Phase/Status/Sponsor: Unknown phase; RECRUITING; RefleXion Medical.

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- This trial tests a two-step, neoadjuvant treatment for intrahepatic cholangiocarcinoma (ICC): 12 weeks of capecitabine plus Selective Internal Radiation Therapy (SIRT) with Yttrium-90, given before surgery. - The goal is to see if this approach can shrink or downstage tumors so surgery is more feasible and potentially more successful, compared with upfront surgery. - It is for adults with histologically confirmed ICC that surgeons consider resectable but at high risk for close margins; key exclusions include severe liver disease or poor organ function, prior ICC chemotherapy, contraindication to hepatic artery catheterization, pregnant status, and other active cancers. - Participants are randomly assigned to the experimental neoadjuvant treatment or to the standard approach of immediate surgery, with long-term follow-up to compare outcomes.

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This is a French multicenter, retrospective, observational study that is currently recruiting to study rare primary liver cancers. It includes adults 18 and older with histologically confirmed hepato-cholangiocarcinoma, fibrolamellar hepatocellular carcinoma, epithelioid hemangioendothelioma, or hepatic angiosarcoma diagnosed after January 1, 2018. The study aims to describe clinical, histological and radiological features, collect tumor tissue and blood, and evaluate how treatments used in real-world care have performed to help determine the best sequencing of therapies. Key exclusions are lack of social security and no access to tumor tissue; living participants must consent to research for ancillary studies.

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HepQuant: Study to Assess the Role of Blood-based Biomarkers and Quantitative MR Imaging for Patients Receiving Radiation Therapy for Liver Cancer is being studied. Conditions: Liver Cancer, Hepatocellular Carcinoma, Hepatocellular Cancer +2 • Eligibility: The following criteria must be met for subjects to be considered for the trial. Additional exclusion criteria must be met for subjects interested in the HepQuant subset of…. Goal: This is a pilot and feasibility study assessing the role of quantitative multiparametric MRI and blood-based biomarkers for the measurement of liver function in patients receiving radiation therapy for liver cancer, including hepatocellular carcinoma (HCC), cholangiocarcinoma, or liver metastases regardless of primary histology, that are undergoing photon radiation either in the de-novo or re-irradiation setting. The goal of this study is to prospectively evaluate the feasibility of using quantitative multiparametric MRI to monitor liver function at baseline and following liver radiation therapy. Phase/Status/Sponsor: Unknown phase; RECRUITING; Montefiore Medical Center.

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Adoptive Transfer of Tumor Infiltrating Lymphocytes for Biliary Tract Cancers is being studied. Conditions: Biliary Tract Cancer, Cholangiocarcinoma, Biliary Tract Neoplasms • Eligibility: Inclusion Criteria: * Measurable locally advanced, recurrent, or metastatic biliary tract carcinoma (including intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer, or ampullary carcinoma). * Patients with locally advanced disease…. Goal: This is a Phase 2 study to evaluate the efficacy, using objective response rate, of a non-myeloablative lymphodepleting preparative regimen followed by infusion of autologous Tumor Infiltrating Lymphocytes (TIL) and high-dose aldesleukin in patients with locally advanced, recurrent, or metastatic biliary tract cancer. These are low-incidence cancers carry a poor prognosis. Phase/Status/Sponsor: Unknown phase; RECRUITING; Udai Kammula.

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Intraperitoneal Aerosolized Nanoliposomal Irinotecan (Nal-IRI) in Peritoneal Carcinomatosis From Gastrointestinal Cancer is being studied. Conditions: Peritoneal Carcinomatosis, Peritoneal Metastases, Colorectal Cancer +5 • Eligibility: Inclusion Criteria: * Biopsy proven cancer of the pancreas, gallbladder or biliary tract, stomach, small bowel, colon, rectum, or appendix with extensive or irresectable peritoneal carcinomatosis * Estimated…. Goal: The PIPAC NAL-IRI study is designed to examine the maximal tolerated dose of nanoliposomal irinotecan (Nal-IRI, Onivyde) administered with repeated pressurized intraperitoneal aerosol chemotherapy (PIPAC), in a monocentric, phase I trial. Phase/Status/Sponsor: Unknown phase; RECRUITING; University Hospital, Ghent.

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Quality of Care in Relationship to Aborted Cancer Surgery is being studied. Conditions: Cancer, Gastrointestinal Cancer • Eligibility: Inclusion Criteria: * \>18 years * cancer patients with different gastrointestinal cancer diagnosis Exclusion Criteria: \- not able to answer the questionnarie SCNS-SF34 in Swedish.. Goal: Surgery is often a central curative treatment for gastrointestinal tumors. Surgical treatment of diagnosed cancer tumors is decided after a comprehensive assessment of the patient's physical status, radiological assessments and after careful evaluation at the multidisciplinary conference. Phase/Status/Sponsor: Unknown phase; RECRUITING; Linkoeping University.

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This is an early access study testing the drug ivosidenib in adults with previously treated, locally advanced or metastatic cholangiocarcinoma that has an IDH1 mutation. The study is open-label and single-arm: eligible participants receive ivosidenib 500 mg daily in 28-day cycles to look at safety and effectiveness. Researchers want to learn whether ivosidenib remains safe and helpful in this setting and how it affects patients’ quality of life, with regular visits and assessments during and after treatment. Key exclusions include prior IDH1 inhibitors, brain metastases requiring steroids, active hepatitis B or C or HIV infection, recent systemic therapy or major surgery, transplant, and pregnancy or breastfeeding.

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This multicenter study tests whether liver transplantation after downstaging unresectable perihilar cholangiocarcinoma can be effective, using chemotherapy with or without the immunotherapy drug durvalumab and SBRT to shrink and control the cancer before transplant. It is for adults aged 18 to 70 with unresectable peripheral cholangiocarcinoma that is small (≤3 cm) and located at least 1 cm above the superior pancreatic margin, with no metastases or hilar lymph node involvement, and who meet the study criteria. The trial aims to learn whether this downstaging approach followed by transplant listing and transplantation can achieve disease control and successful transplantation, with regular restaging and a listing-to-transplant target under 90 days. Exclusions include intrahepatic cholangiocarcinoma, uncontrolled infection, or a history of other cancers within the past five years.

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- The study tests a CLDN18.2-targeted PET imaging probe to visualize CLDN18.2 expression in tumors, using PET/MR or PET/CT, and also in healthy volunteers for safety. - It includes adults with suspected or confirmed gastric, pancreatic, bile duct, or other CLDN18.2-expressing cancers, plus healthy volunteers for pharmacokinetic study. - In cancer patients, the trial will assess how well CLDN18.2 PET detects tumor lesions, compare findings with histopathology, map location and metabolic features, and explore its use for guiding treatment decisions and predicting response versus FDG PET. - Exclusions include inability to complete scans, allergies to the imaging agent, significant comorbidities, and high fasting glucose (above 11.0 mmol/L) before FDG injection.

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Phase I/II Study: Allogeneic NK-cell Therapy With Chemotherapy for Post-Surgery PDA or Cholangiocarcinoma Patients is being studied. Conditions: Pancreatic Carcinoma Stage II, Cholangiocarcinoma Resectable • Eligibility: Inclusion Criteria: 1. Dated and signed informed consent. 2. Either sex, aged older than 18 years old (inclusive) at date of consent. 3. Subject with a macroscopic resection…. Goal: This is a phase I/II study which intends to characterize the safety, tolerability, and preliminary efficacy of Allogeneic Magicell-NK infusion in PDA or cholangiocarcinoma patients after surgery. Subjects will receive a total of 6 intravenous (IV) infusions of the IP on the 11th day of each chemotherapy cycle. Phase/Status/Sponsor: Unknown phase; RECRUITING; Medigen Biotechnology Corporation.

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A Phase 1 Study of LNCB74 in Advanced Solid Tumors is being studied. Conditions: Ovarian Cancer, Breast Cancer, Endometrial Cancer +3 • Eligibility: Inclusion Criteria: 1. The participant provides written informed consent 2. ≥ 18 years of age on day of signing informed consent. 3. Participant with histologically or cytologically confirmed…. Goal: This is an open-label, phase 1, dose escalation and dose expansion study to determine safety and tolerability, and to determine the maximum tolerated dose and / or recommended phase 2 dose of LNCB74 in participants with advanced solid tumors. Phase/Status/Sponsor: Unknown phase; RECRUITING; NextCure, Inc..

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A Study of GC203 TIL in Advanced Malignant Solid Tumors is being studied. Conditions: Solid Tumor, Gynecologic Cancer, Breast Cancer +2 • Eligibility: Inclusion Criteria: * 1\. In the opinion of the Investigator, patients must be able to sign the ICF and complete all study-required procedures. 2\. Patients must be ≥18…. Goal: A clinical trial to assess the safety and efficacy of engineered Tumor Infiltrating Lymphocytes (TIL) for the treatment of Advanced Malignant Solid Tumors Phase/Status/Sponsor: Unknown phase; RECRUITING; Shanghai Juncell Therapeutics.

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A Study of MT-4561 in Patients With Various Advanced Solid Tumors is being studied. Conditions: Head and Neck Squamous Cell Carcinoma (HNSCC), Non-small Cell Lung Cancer (NSCLC), Esophageal Cancer +13 • Eligibility: Main Inclusion Criteria: Patients who have failed at least 1 prior therapy and, who have no standard treatment options demonstrated to provide clinical benefit or who are intolerable…. Goal: This is a First In Human (FIH), multicenter, open-label, Phase I/II study to evaluate safety, tolerability, Pharmacokinetics (PK), pharmacodynamics, and efficacy of MT-4561 in patients with advanced solid tumors. This study will be conducted in 3 parts. Phase/Status/Sponsor: Unknown phase; RECRUITING; Tanabe Pharma America, Inc..

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Durvalumab + Intraductal Radiofrequency Ablation (ID-RFA) in Extrahepatic Cholangiocarcinoma is being studied. Conditions: Extrahepatic Cholangiocarcinoma, Unresectable Perihilar or Ductal CCA • Eligibility: Inclusion Criteria: 1. Patient\* has given written informed consent. 2. Patient is ≥ 18 years of age at time of signing the written informed consent. 3. Patient is…. Goal: The present clinical trial is a prospective, investigator-initiated, single-arm, open-label, multicenter phase II trial. Patients with unresectable perihilar and/or ductal CCA with indication for bile duct stenting and palliative systemic therapy as determined by the local multidisciplinary team (MDT), who already resolved cholestasis due to RFA + Stent will be enrolled. Phase/Status/Sponsor: Unknown phase; RECRUITING; Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest.

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Cryoablation Combined With Lenvatinib Plus QL1706 (Iparomlimab/Tuvonralimab) in Patients With Advanced Intrahepatic Cholangiocarcinoma is being studied. Conditions: Intrahepatic Cholangiocarcinoma (Icc) • Eligibility: Inclusion Criteria: * Written informed consent obtained. * Age ≥ 18 years at time of study entry. * Participants must have unresectable or metastatic histologically or cytologically confirmed…. Goal: This study will evaluate the efficacy and safety of cryoablation combined with lenvatinib plus QL1706 (iparomlimab/tuvonralimab) in patients with advanced Intrahepatic Cholangiocarcinoma (ICC) who have progressed after first-line treatment. Phase/Status/Sponsor: Unknown phase; RECRUITING; Fudan University.

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- This trial tests a streamlined approach to transarterial radioembolization (TARE) for liver cancer, using SIR-Spheres in a same-day, single-session procedure without full pre-procedural nuclear imaging for eligible patients. - It is for adults with metastatic liver cancer or cholangiocarcinoma whose largest tumor is 7 cm or smaller, up to five tumors, enough healthy liver tissue, good liver function (Child-Pugh A), and good performance status (ECOG ≤1). - The study aims to determine if this faster method can be safely delivered, with predefined dosing rules (lung shunt assumed 5%, lung dose ≤10 Gy) and post-treatment dosimetry the next day, followed for one year. - Exclusions include hepatic vein invasion or hepatic vein enhancement, dysmorphic intratumoral vessels >3 mm, TIPS, major portal vein issues, biliary stents, allergy to contrast, or other factors that could raise the risk of radiation pneumonitis.

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Raman Spectroscopy in the Diagnosis of Extrahepatic Cholangiocarcinoma - a Pilot Study is being studied. Conditions: Cholangiocarcinoma, Extrahepatic, Cholangiocarcinoma of the Extrahepatic Bile Duct, Cholangiocarcinoma, Perihilar +6 • Eligibility: Inclusion Criteria: * person older than 18 years, who has known extrahepatic cholangiocarcinoma and is indicated for ERCP Exclusion Criteria: * disagreement with the study. Goal: Diagnosis of extrahepatic cholangiocarcinoma is challenging because the yield of imaging and tissue sampling is limited. Raman spectroscopy is an optical method based on the analysis of scattered monochromatic light. Phase/Status/Sponsor: Unknown phase; RECRUITING; University Hospital Olomouc.

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This randomized trial tests whether extensive washing of the abdomen during pancreatic cancer surgery helps people live longer, using either saline (EIPL-S) or distilled water (EIPL-D) after tumor removal, or no washing at all. It is for adults with suspected pancreatic or periampullary cancer who are planned to have a pancreatectomy (removal of the pancreas or part of it). The study aims to learn overall survival, disease-free survival, complication rate, where cancer first returns, and how many cancer cells are cleared by the lavage. Participants are randomly assigned to three groups: saline lavage, distilled water lavage, or no lavage after tumor removal. Key exclusions include not being a surgical candidate for pancreatectomy, age under 18, contraindications to pancreatectomy, or evidence of metastatic disease before surgery.

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- This trial tests a first-line treatment for unresectable intrahepatic cholangiocarcinoma using FOLFOX-based hepatic arterial infusion chemotherapy with donafenib and pucotenlimab. - It is a prospective, open-label, single-arm phase II study and is not yet recruiting. - The primary goal is to measure the objective response rate, with secondary goals including progression-free survival, overall survival, disease control rate, and safety. - Eligible participants are adults up to 75 years old; key exclusions include prior anti-PD-1/PD-L1 therapy, active CNS metastases, autoimmune disease requiring systemic treatment, active infection, HBV DNA > 2000 IU/mL, HIV, syphilis, and pregnancy.

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Preoperative Right Hepatic Artery Embolization for Locally Advanced Bismuth IIIb and IV Perihilar Cholangiocarcinoma is being studied. Conditions: Cholangiocarcinoma Non-resectable • Eligibility: Inclusion Criteria: * Signed informed consent. * Age 18-80 years. * Clinical diagnosis of Bismuth IIIb or IV perihilar cholangiocarcinoma, deemed suitable for radical resection via left hepatectomy…. Goal: This is a prospective, multicenter, single-arm study investigating the efficacy and safety of preoperative right hepatic artery embolization (PHAE) followed by surgical resection in patients with locally advanced Bismuth IIIb or IV perihilar cholangiocarcinoma (PHCC) involving the right hepatic artery. The standard treatment for such cases is often considered unresectable due to the high risk of hepatic ischemia after arterial resection without reconstruction. Phase/Status/Sponsor: Unknown phase; NOT_YET_RECRUITING; Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.

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- This trial tests whether using 3D-PTA drug-sensitivity testing to guide chemotherapy plus capecitabine is better as adjuvant treatment after surgery for stage II/III biliary tract cancers than capecitabine alone. - It is for adults who have had radical surgery for biliary tract cancers (including cholangiocarcinoma and gallbladder cancer) and are fit for chemotherapy (ECOG 0–1). - The study will measure tumor response, safety, quality of life, and survival to see if personalized 3D-PTA-guided therapy improves outcomes. - Exclusions include distant metastasis, early-stage disease, other active cancers, significant organ or immune problems, active infection, or inability to take oral chemotherapy.

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- This trial tests a combination of Iparomlimab and Tuvonralimab Injection (QL1706) with GemOX chemotherapy and lenvatinib as conversion therapy for initially potentially resectable intrahepatic cholangiocarcinoma and gallbladder cancer. - It is for adults (18 years and older) who have locally advanced or potentially resectable disease, have not had prior systemic therapy for biliary tract cancer, and have at least one measurable tumor. - The study aims to learn how well this treatment can convert tumors to a state where surgery might be possible and how safe it is. - Key exclusions include prior anticancer therapy, active autoimmune disease, HIV infection, uncontrolled heart disease, recent or active other cancers, and extensive liver metastases.

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The trial tests PSMA-targeted imaging and PSMA expression in biopsy tissue for patients with newly diagnosed gastroenterologic tumors. It aims to see if PSMA-PET can detect more disease sites than standard imaging and whether the PSMA signal can predict outcomes under guideline-based treatment. Eligible participants are adults with newly diagnosed GET before starting guideline-compatible anti-tumor therapy, with available tumor tissue and the ability to consent and follow up. Exclusions include curative-intent treatment, insufficient tumor tissue, history of other cancers, pregnancy or breastfeeding, contraindications to PET/CT, and men with prostate cancer. The study is sponsored by Würzburg University Hospital and is currently recruiting.

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A Study of BL-M17D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Lower Expression Gastrointestinal Cancer and Other Solid Tumors is being studied. Conditions: Esophageal Cancer, Gastric Cancer, Pancreatic Cancer +2 • Eligibility: Inclusion Criteria: 1. Voluntarily sign the informed consent and follow the requirements of the protocol; 2. No gender limit; 3. Age: ≥18 years old and ≤75 years old…. Goal: This study is an open, multicenter, dose-escalation and expansion-enrollment nonrandomized phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-M17D1 in locally advanced or metastatic HER2 positive/lower expression gastrointestinal cancer and other solid tumors. Phase/Status/Sponsor: Unknown phase; RECRUITING; Sichuan Baili Pharmaceutical Co., Ltd..

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- The study tests a drug called MGC028 in adults whose ADAM9-expressing solid tumors are relapsed or refractory, unresectable, locally advanced, or metastatic. - It uses dose escalation to find a safe dose and to describe safety and side effects, including any dose-limiting toxicities and the highest dose that can be given safely. - The trial also aims to learn whether MGC028 can shrink tumors, keep cancer from growing, or control disease in these advanced cancers. - Cancers eligible for participation include NSCLC adenocarcinoma, cholangiocarcinoma, colorectal cancer, and pancreatic cancer with specific prior-treatment criteria; key exclusions include active brain metastases, prior ADAM9-targeted therapy, recent major cancer treatment, organ transplant, infection, and pregnancy.

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Study of Large Channel Digital Pancreaticobiliary Scope (DPS) With Compatible Accessories is being studied. Conditions: Bile Duct Adenocarcinoma, Bile Duct Carcinoma • Eligibility: Inclusion Criteria: 1. Provision to sign and date the consent form; 2. Adult patients ≥ 21 years old; 3. Any patient who is required to undergo endoscopic retrograde…. Goal: This study plans to enroll up to 75 research subject who have a biliary disorder such as bile duct stones or intermediate biliary strictures. The purpose of this research is to assess whether the Dragonfly™ Pancreaticobiliary Scope functioned as intended in combination with the commercially available accessories during your scheduled endoscopy procedure. Phase/Status/Sponsor: Unknown phase; RECRUITING; University of Colorado, Denver.

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- The trial tests whether adding Camrelizumab and rivoceranib to hepatic arterial infusion chemotherapy (HAIC) is safe and effective for advanced mixed hepatocellular-cholangiocarcinoma (HCC-CCA). - It is for adults whose disease cannot be cured or controlled with curative or local therapies and who have histologically confirmed mixed HCC-CCA. - This is a single-arm Phase II study designed to learn about tumor response and overall safety of the combination. - Key exclusions include prior systemic cancer therapy or immunotherapy, certain heart or autoimmune conditions, HIV, pregnancy, and active infections.

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Sequential Anti-Angiogenic Therapy After Immunotherapy in Advanced Biliary Tract Cancer is being studied. Conditions: Bile Duct Carcinoma, Gall Bladder Cancer, Biliary Tract Cancer +1 • Eligibility: Inclusion Criteria: Age 18-75 years at time of enrollment; Histologically or cytologically confirmed advanced or metastatic biliary tract adenocarcinoma (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder carcinoma); Unresectable locally…. Goal: Brief Summary: This study is for patients with advanced biliary tract cancer (cancer of the bile ducts or gallbladder). The purpose is to find out if using anti-blood vessel formation drugs after immunotherapy treatment can help patients live longer without their cancer getting worse. Phase/Status/Sponsor: Unknown phase; RECRUITING; First Affiliated Hospital of Zhejiang University.

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- The trial tests whether eccDNA biomarkers found in bile can help diagnose malignant biliary strictures. - It is for adults with suspected indeterminate biliary stricture who are planned to undergo ERCP. - The study aims to learn how accurately these eccDNA markers can distinguish malignant from non-malignant stricture causes. - Key exclusions include ERCP failure or inability to obtain bile, severe comorbidities, predicted survival less than 1 year due to another disease, or inability to comply with the protocol or follow-up. - The study is sponsored by Peking University Third Hospital and is currently recruiting.

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Summary not available yet.

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This study tests adding elimusertib (BAY 1895344) to standard chemotherapy with cisplatin, or cisplatin plus gemcitabine, for adults with advanced solid tumors, including urothelial cancer. It is a dose-escalation phase I trial to find the safest and most effective dose and to learn how the combination behaves in the body. The trial will assess safety and tolerability, identify the maximum tolerated dose, and collect pharmacokinetics and early signs of activity, with a focus on urothelial cancer in the triplet arm. Eligible participants are adults 18 or older with measurable advanced disease for which cisplatin-based therapy is suitable; key exclusions include pregnancy, life expectancy under 6 weeks, uncontrolled illness, recent chemotherapy or radiotherapy, and certain drug interactions or prior ATR inhibitors. The study is currently active but not recruiting.

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A Study to Determine Whether Chemotherapy and Atezolizumab is Better Than Chemotherapy, Bevacizumab and Atezolizumab in Patients With Advanced Liver Cancer is being studied. Conditions: Combined Hepatocellular Carcinoma and Cholangiocarcinoma, Stage III Liver Cancer, Stage IV Liver Cancer • Eligibility: Inclusion Criteria: * Patient must be \>= 18 years of age * Patient must have a histologically confirmed diagnosis of combined hepatocellular carcinoma-cholangiocarcinoma (cHCC-CC) at the local laboratory…. Goal: This phase II trial compares the effect of adding bevacizumab and atezolizumab to gemcitabine and cisplatin (chemotherapy) versus chemotherapy and atezolizumab in treating patients with liver cancer that cannot be removed by surgery (unresectable) or that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Phase/Status/Sponsor: Unknown phase; ACTIVE_NOT_RECRUITING; National Cancer Institute (NCI).

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- This study tests the combination of nivolumab and ipilimumab in adults with rare cancers to see if it can shrink tumors or slow their growth. - It includes many different rare tumor types in separate groups, plus a PD-L1–amplified cohort that uses nivolumab alone, and it measures how often tumors respond using standard criteria. - The trial also looks at safety, overall survival, and progression-free survival across cohorts. - Eligible participants must have progressed after prior therapy and generally cannot have active brain metastases or uncontrolled autoimmune disease; some cohorts have additional specific requirements or exclusions.

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- This trial tests olaparib, a drug that may slow tumor growth, in adults with glioma, cholangiocarcinoma, or other solid tumors that have IDH1 or IDH2 mutations and have progressed after standard treatment. - Participants are grouped into three cohorts: glioma, cholangiocarcinoma, and other IDH-mutant solid tumors, to see how they respond to olaparib. - The study aims to learn the overall response rate, how long patients live without the disease getting worse, overall survival, duration of responses, and the safety of olaparib alone. - Researchers will measure blood and tumor markers, including a molecule called 2HG, to see if these relate to treatment response. - Key exclusions include active uncontrolled brain metastases, prior PARP inhibitor therapy, pregnancy, HIV infection on antiretroviral therapy, and other serious medical conditions.

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This is an exploratory study to see how the PET/CT tracer 68Ga-FAPi-46 distributes in normal and cancer tissue and how much it accumulates, with tissue validation. It includes adults with a variety of cancers who are planned for surgical resection or biopsy, to compare imaging results with the actual tumor tissue. The study aims to define biodistribution, measure PET uptake, and relate it to FAP levels and to other tracers like 18F-FDG (and, if available, DOTATATE or FDOPA). Exclusions include pregnancy or nursing, starting new cancer therapy between scans, or conditions that could interfere with data; the trial is currently active but not recruiting.

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This is a not-yet-recruiting, single-arm Phase II trial testing whether Sintilimab plus Bevacizumab and AG chemotherapy can be given as first-line treatment for adults with unresectable locally advanced or metastatic cholangiocarcinoma. The study is for adults aged 18–75 who have surgically unresectable disease, no prior systemic therapy (except some postoperative therapy more than 6 months ago), and at least one measurable lesion. It aims to learn how often tumors respond, how many patients have disease control, how long responses last, overall survival, and safety, and it will also explore biomarker signals like PD-L1 and tumor mutational burden. Key exclusions include prior anti-PD-1/PD-L1 therapy, active autoimmune disease needing systemic treatment, HIV, active HBV or HCV infection, pregnancy, high bleeding risk, and recent major surgery.

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Yueju Pill Combined With Standard Therapy In Advanced Biliary Tract Cancer is being studied. Conditions: Biliary Tract Cancer (BTC) • Eligibility: Inclusion Criteria: Subjects must meet all of the following criteria to be enrolled in this study: 1. No gender restriction, age ≥18 years, and expected survival ≥3 months;…. Goal: This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the impact of Yueju Pill on quality of life and treatment efficacy in patients with advanced biliary tract cancer (BTC) receiving standard therapy. Phase/Status/Sponsor: Unknown phase; NOT_YET_RECRUITING; Fudan University.

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This is a randomized, open-label, single-center trial testing two first-line treatments for advanced intrahepatic cholangiocarcinoma (ICC). It compares Iparomlimab and Tuvonralimab plus GC with Sintilimab plus GC to see which therapy is more effective and safe as initial treatment. The main goal is to measure the 6-month progression-free survival rate, with secondary goals including response rate, duration of response, time to response, progression-free survival, overall survival, and safety. About 104 adults aged 18–75 with unresectable or metastatic ICC who have not yet had systemic therapy for advanced disease will be enrolled; key exclusions include active autoimmune disease needing systemic therapy, HIV, active hepatitis B or C, recent systemic corticosteroid or immunosuppressant use, pregnancy or breastfeeding, prior immunotherapy for advanced disease, and certain uncontrolled conditions.

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Summary not available yet.

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- This is a single-arm Phase II trial testing adjuvant concurrent chemoradiotherapy with a simultaneous integrated boost after hepatectomy for intrahepatic cholangiocarcinoma with a very narrow margin or positive lymph nodes. - It is for adults aged 18 to 80 who had surgery for intrahepatic cholangiocarcinoma and have narrow margins or nodal involvement. - During radiotherapy, patients receive capecitabine, followed by maintenance capecitabine after treatment; S-1 is available if capecitabine cannot be tolerated. - The main goal is to learn 2-year recurrence-free survival, with secondary goals including 2-year overall survival, local-regional control, and safety (grade 3+ adverse events). - Exclusions include history of other cancers (except basal cell skin cancer or in situ cervical cancer), prior abdominal irradiation or liver transplant, serious heart or kidney disease, moderate/severe ascites within 4 months after surgery, or a surgery-to-enrollment interval of 4 months or more.

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- This study tests whether adding Yttrium-90 radiation to a chemotherapy/immunotherapy combo (gemcitabine, cisplatin, and durvalumab) can better shrink tumors and control intrahepatic cholangiocarcinoma (iCCA) that cannot be removed by surgery. - It is for adults 18 and older with unresectable, measurable iCCA and good performance status, who may have had prior systemic therapy as long as it was at least 6 months before new disease. - The trial aims to learn if this multi-modality approach is safe and more effective at shrinking tumors and controlling cancer than standard options. - Key exclusions include pregnancy, active autoimmune disease (with some allowed exceptions), significant liver disease or untreated hepatitis, contraindications to the study drugs, and extensive disease outside the liver.

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- This is a multicenter, prospective, single-arm phase II trial testing a combination therapy for adults with unresectable intrahepatic cholangiocarcinoma (ICC). - It evaluates D-TACE-HAIC using the GEMOX protocol together with Envafolimab and Lenvatinib. - The study aims to learn how effective and safe this treatment is in eligible participants. - Eligible participants are adults aged 18 to 75 with pathologically confirmed unresectable ICC and adequate liver and overall function, who have not previously received tumor-targeted, immunotherapy, radiotherapy, or chemotherapy. - Key exclusions include prior local anti-tumor treatments, autoimmune disease or immune suppression, active infection, pregnancy or breastfeeding, organ transplant, and other cancers within the past five years, among other criteria.

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The trial tests whether combining bile-based molecular testing with standard biliary brush cytology/biopsy can improve detection of malignant biliary strictures. It is for adults aged 18–90 who have indeterminate biliary strictures and have undergone ERCP with biliary biopsy and/or brush cytology. Researchers will collect bile and screen for molecular markers using multi-omics to develop and validate a bile-based diagnostic model. Exclusions include coagulation disorders, pregnancy, other cancers not related to biliary strictures, or those who decline participation. The study is currently recruiting.

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The study is a prospective randomized trial comparing two ERCP cannulation techniques: Precut needle-knife precut versus the Intentional Double Guidewire Technique. It targets adults with biliary obstruction who need ERCP and have a native papilla with difficult cannulation (per ESGE 5-5-2). The goal is to learn which method provides better biliary access and has a safer profile during difficult cannulation. Eligible participants are adults over 18 with benign or malignant obstruction and no prior sphincterotomy; key exclusions include ampullary mass, surgically altered anatomy, uncorrectable coagulopathy, or acute pancreatitis before ERCP.

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Efficacy and Safety of TT-00420 (Tinengotinib) Tablets Versus Chemotherapy in Patients With Advanced Intrahepatic Cholangiocarcinoma Harboring FGFR2 Fusions/Rearrangements or Mutations is being studied. Conditions: Intrahepatic Cholangiocarcinoma (Icc), Advanced Cholangiocarcinoma • Eligibility: Inclusion Criteria: 1. ≥ 18 years of age at the time of signing the informed consent form (ICF). 2. Histologically or cytologically confirmed intrahepatic cholangiocarcinoma. 3. Subjects diagnosed…. Goal: This is an open-label, randomized, controlled, multicenter, phase III clinical study designed to evaluate the efficacy and safety of TT-00420 tablets as monotherapy versus chemotherapy in subjects with unresectable advanced or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 gene fusions/rearrangements or mutations, who have experienced recurrence or progression after prior first-line systemic chemotherapy. Phase/Status/Sponsor: Unknown phase; NOT_YET_RECRUITING; TransThera Sciences (Nanjing), Inc..

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A Randomized Trial of Surgical Decision-Making Guided by TDTP-RECIST is being studied. Conditions: Intrahepatic Cholangiocarcinoma (Icc), Conversion Therapy, TDTP-RECIST +1 • Eligibility: Inclusion Criteria: \- Subjects eligible to participate in this study must meet all of the following criteria: 1. Male or female aged 18-75 years; 2. Patients must provide…. Goal: This project aims to conduct a prospective, multicenter, randomized controlled clinical trial. The study plans to enroll 270 patients with locally advanced iCCA who have successfully undergone GOLP conversion therapy. Phase/Status/Sponsor: Unknown phase; NOT_YET_RECRUITING; Shanghai Zhongshan Hospital.

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A Clinical Study of SPH5030 Tablets in the Treatment of Her2-positive/Mutated Biliary Tract OR Colorectal Cancer Patients. is being studied. Conditions: Biliary Tract or Colorectal Cancer With Her2-positive/Mutated • Eligibility: Inclusion Criteria: 1. Metastatic and/or unresectable advanced colorectal adenocarcinoma, or locally advanced, recurrent, metastatic and/or unresectable advanced biliary tract carcinoma 2. HER2 positive or HER2 gene mutation; 3.…. Goal: To evaluate the efficacy and safety of SPH5030 tablets in subjects with Her2-positive/mutated biliary tract OR colorectal cancer. Phase/Status/Sponsor: Unknown phase; RECRUITING; Shanghai Pharmaceuticals Holding Co., Ltd.

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- The trial tests whether adding peginterferon alfa-2b to standard nucleos(t)ide analogue therapy can reduce recurrence of HBV-related liver cancer after radical treatment. - It is for adults aged 18-70 who are HBV surface antigen positive and have hepatocellular carcinoma treated with surgery or ablation, with good liver function (BCLC 0-A, Child-Pugh A). - The study is single-center, non-randomized, open-label, comparing NAs alone versus NAs plus peginterferon alfa-2b to see if it lowers the 3-year recurrence rate and may improve cure. - Participants will undergo regular imaging and blood tests every few months to monitor recurrence and safety. - Key exclusions include prior systemic cancer treatments, other active cancers, allergy to interferon, severe liver or kidney disease, autoimmune disease, pregnancy, or participation in other trials.

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The Spanish Registry of Direct Cholangiopancreatoscopy by Single Operator will collect real-world data on using direct cholangiopancreatoscopy, performed by a single operator, for biliary and pancreatic duct problems. It will enroll adults undergoing this procedure at participating centers starting June 1, 2025. The study aims to confirm technical feasibility, assess effectiveness and safety, and evaluate cost-effectiveness to determine where in the clinical pathway this technique should be used. Eligibility requires age 18 or older, signed informed consent, and the ability to follow up; those under 18, without consent, or with follow-up is not possible are excluded.

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Proteomic Profiling to Differentiate Pancreatic and Biliary Adenocarcinomas is being studied. Conditions: Pancreatic Adenocarcinoma • Eligibility: Inclusion Criteria: * Patients ≥ 18 years old * Pancreaticoduodenectomy for pancreatic adenocarcinoma or distal cholangiocarcinoma * Patient's non-opposition to the reuse of data Exclusion Criteria: * Neoadjuvant…. Goal: Distal cholangiocarcinoma and pancreatic adenocarcinoma are aggressive cancers with overlapping diagnostic features, making them challenging to differentiate. Although both require similar surgical treatment, their postoperative chemotherapy regimens differ significantly, with capecitabine used for distal cholangiocarcinoma and modified FOLFIRINOX for pancreatic adenocarcinoma, based on distinct guidelines. Phase/Status/Sponsor: Unknown phase; NOT_YET_RECRUITING; University Hospital, Bordeaux.

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Validation of the Proteomic Profiling as a Diagnostic Test for Extra-hepatic Cholangiocarcinoma is being studied. Conditions: Cholangiocarcinoma • Eligibility: Inclusion Criteria: * Age ≥ 18 years * Patient with biliary stenosis of undetermined origin who has had an endo-biliary cytological sample (biopsy and/or brushing) for suspected cholangiocarcinoma,…. Goal: The study aims to valide a proof of a concept of the proteomic profiling as a diagnostic tool for bile duct stenosis suspicious of cholangiocarcinoma. The main objective is to evaluate the addition of proteomic profiling to the conventional histological diagnosis of endo-biliary cytological sampling of biliary stenosis, compared with cytological sampling alone. Phase/Status/Sponsor: Unknown phase; NOT_YET_RECRUITING; University Hospital, Bordeaux.

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A Clinical Trail of KJ015 in Patients With HER2-Expressing Solid Tumors is being studied. Conditions: Gastric/Gastroesophageal Junction Cancer, Breast Cancer, Colorectal Cancer +3 • Eligibility: Inclusion Criteria: 1. Aged ≥ 18 years (at time of free and informed consent). 2. Participants must have radiographically confirmed progressive disease (PD) during the last treatment prior…. Goal: This is an open-label, multicenter, Phase 1 study to evaluate the safety, tolerability, PK, and preliminary efficacy of KJ015 administered subcutaneously in participants with HER2-expressing solid tumors. Phase/Status/Sponsor: Unknown phase; NOT_YET_RECRUITING; Shanghai Bao Pharmaceuticals Co., Ltd..

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- The study tests pimitespib in combination with imatinib for patients with gastrointestinal stromal tumors (GIST) that have progressed on imatinib. - It has a dose-escalation part to find the maximum tolerated dose and the recommended dose, while assessing safety, pharmacokinetics, and early antitumor activity, followed by an expansion part with three arms. - Arm A evaluates the combination in patients who progressed on imatinib at doses below the determined MTD; Arm B tests pimitespib alone and also explores giving imatinib after pimitespib; Arm C uses sunitinib monotherapy as a reference. - Eligibility includes histologically confirmed GIST, radiographic progression on or after imatinib, at least one measurable lesion, and ECOG 0-1 with informed consent. - Exclusion criteria include severe vision impairment, prior therapy beyond imatinib for advanced GIST, prior extensive gastrectomy or small-bowel resection, serious illness, other active cancers, and pregnancy or lactation.

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- This is a phase II, single-arm trial testing a combination of tremelimumab with durvalumab (STRIDE) plus gemcitabine and cisplatin for adults with locally advanced unresectable or metastatic combined hepatocellular-cholangiocarcinoma (cHCC-CCA). - The study aims to learn about the safety of this regimen and whether it can shrink or control tumors, with regular disease assessments and treatment continuing until progression or toxicity. - Participants should be adults with measurable disease and adequate organ function; the study is not yet recruiting. - Key exclusions include active brain metastases, severe autoimmune disease, active infection, prior immunotherapy or gemcitabine/cisplatin for this disease, and pregnancy.

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- This is a retrospective study testing whether vascular resection during surgery for hilar cholangiocarcinoma affects survival and postoperative outcomes. - It includes patients who had curative-intent surgery for hilar cholangiocarcinoma at the hospital between 2010 and 2024, with or without vascular resection. - The researchers will compare those who had vascular resection to those who did not to learn how this impacts survival and recovery after surgery. - The study is not recruiting new participants and uses existing medical records and follow-up data. - Exclusions include patients with distant metastasis or who had only palliative or exploratory surgery, those with biliary cancers not located at the hilar region, and cases with incomplete data.

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Treatment of Atezolizumab and Derazantinib in Patients With Advanced iCCA With FGFR2 Fusions/Rearrangements is being studied. Conditions: Intrahepatic Cholangiocarcinoma • Eligibility: Inclusion Criteria: Patients must meet all of the following criteria to be eligible for the study: 1. Fully informed written consent and locally required authorization (European Union \[EU\]…. Goal: The study trial is a open-label, single-arm, multicenter phase II trial investigating the combined treatment of atezolizumab and derazantinib in patients with advanced intrahepatic cholangiocarcinoma with FGFR2 fusions/rearrangements Phase/Status/Sponsor: Unknown phase; ACTIVE_NOT_RECRUITING; Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest.

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Vorbipiprant (CR6086) / Balstilimab (AGEN2034) Combination in Stage IV Refractory pMMR - MSS CRC, and Other Metastatic GI Cancers is being studied. Conditions: Refractory Metastatic Colorectal Cancer, Solid Tumor, Metastatic Microsatellite-stable Colorectal Cancer +3 • Eligibility: Diagnosis and Main Criteria for Inclusion/Exclusion: Inclusion Criteria Main Study - patients with MSS mCRC These criteria are applicable for both Dose Escalation and Expansion part of the…. Goal: This Phase Ib/IIa study comprises a Main Study and a Study Extension. The Main Study has been designed according to a 3+3 Dose Escalation/dose Expansion design in refractory pMMR-MSS mCRC patients. Phase/Status/Sponsor: Unknown phase; ACTIVE_NOT_RECRUITING; Rottapharm Biotech.

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Frailty Scales for Predicting Chemotherapy Toxicity in Older Adults With Gastrointestinal Cancers is being studied. Conditions: Gastrointestinal Cancers, Frailty, Sarcopenia in Elderly +8 • Eligibility: Inclusion Criteria: * Age ≥65 years * Histologically confirmed non-metastatic or locally advanced gastrointestinal cancers (esophageal, gastric, colorectal, pancreatic, biliary tract) * Planned to receive adjuvant chemotherapy (standard…. Goal: This study evaluates the effectiveness of the G8 and VES-13 frailty scales in predicting chemotherapy-related toxicity in older patients with gastrointestinal cancers receiving adjuvant chemotherapy. Older adults are more vulnerable to treatment-related side effects due to age-related declines in physiological reserve. Phase/Status/Sponsor: Unknown phase; ACTIVE_NOT_RECRUITING; Ankara Etlik City Hospital.

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This study tests how liver cancer (hepatocellular carcinoma, HCC) patients respond to interventional therapy combined with systemic therapy and how outcomes vary between individuals. It will look at outcomes like disease control, progression-free survival, patient-reported outcomes, and adverse reactions, and it will study clinical features and biomarkers that relate to this heterogeneity. The goal is to build a machine learning model to predict the risk of adverse reactions to help tailor decisions for each patient. The study is not yet recruiting and will enroll adults with HCC who are receiving or planning interventional therapy with systemic treatment (including DEB-TACE with targeted therapy and/or immunotherapy) or other local interventional treatments; it excludes people with other active cancers, severe cognitive impairment, very limited life expectancy, or decompensated liver function (Child-Pugh C).

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- The trial tests a combination of cryoablation, SHR-1701 (a PD-L1 and TGF-β blocker), and famitinib for advanced intrahepatic cholangiocarcinoma that has progressed after first-line treatment. - It aims to learn how effective and safe this treatment is in adults with unresectable or metastatic ICC. - To participate, you must be 18 or older, have measurable disease, and have failed one line of GemCis plus a PD-1/PD-L1 inhibitor. - The study is not yet recruiting, and key exclusions include significant heart disease, recent thrombosis, active autoimmune disease requiring systemic therapy, active infections, prior cryoablation, or recent major cancer treatment.

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Summary not available yet.

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Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions) is being studied. Conditions: Breast Cancer, Cholangiocarcinoma, Colorectal Cancer +13 • Eligibility: Inclusion Criteria: * Histologically- or cytologically-confirmed diagnosis of locally advanced or metastatic solid tumor that harbors an NTRK1/2/3, ROS1, or ALK gene rearrangement * For patients enrolled via…. Goal: This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for the treatment of patients with solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene fusion. Patients will be assigned to different baskets according to tumor type and gene fusion. Phase/Status/Sponsor: Unknown phase; ACTIVE_NOT_RECRUITING; Hoffmann-La Roche.

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- This study tests the drug ivosidenib in Japanese adults whose cholangiocarcinoma cannot be removed and has an IDH1 mutation. - Participants have already had 1–2 prior treatments and will take ivosidenib daily in 28-day cycles to evaluate safety and potential impact on survival. - The trial will follow participants to learn overall survival and monitor side effects, with regular tumor assessments and health checks. - Key exclusions include prior IDH inhibitors, active brain metastases needing steroids, pregnancy or plans to become pregnant, and certain heart or drug interaction risks (such as QT prolongation or strong CYP3A4 inducers).

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Postbiotics for Mitigation of Postoperative Dysbiosis in Gastrointestinal Cancer Surgery is being studied. Conditions: Colon Cancer, Gastrointestinal Cancer • Eligibility: Inclusion Criteria: 1. Recently diagnosed with nonmetastatic GI cancer, including but not limited to small bowel, colon, rectal, pancreatic, gastric, or hepatic malignancies, and scheduled for an elective…. Goal: To measure the efficacy of postbiotic supplements in mitigating the gut dysbiosis induced by colon cancer surgery. Efficacy in mitigating dysbiosis will be measured by the change in fecal Shannon Diversity Index (SDI) within patients from the baseline sample to various postoperative timepoints. Phase/Status/Sponsor: Unknown phase; ENROLLING_BY_INVITATION; University of South Florida.

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Testing Olaparib and AZD6738 in IDH1 and IDH2 Mutant Tumors is being studied. Conditions: Malignant Solid Neoplasm, Refractory Cholangiocarcinoma, Refractory Malignant Solid Neoplasm • Eligibility: Inclusion Criteria: * Subjects must be able to understand the nature of this trial and provide written informed consent, prior to any study specific procedures. Patients with impaired…. Goal: This phase II trial studies how well olaparib and ceralasertib (AZD6738) work in treating patients with IDH mutant cholangiocarcinoma or solid tumors. Cancer is caused by changes (mutations) to genes that control the way cells function. Phase/Status/Sponsor: Unknown phase; ACTIVE_NOT_RECRUITING; National Cancer Institute (NCI).

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This trial tests whether adding the antidepressant fluoxetine to immunotherapy improves outcomes for people with advanced liver and gallbladder cancers. It is for adults 18 to 80 who have liver cancer or bile duct cancer that has spread or is locally advanced and who are about to start PD-1/PD-L1 inhibitor therapy, and who have depression or anxiety. The researchers want to learn if fluoxetine can better control the cancer, extend survival, and also improve mood and quality of life. Exclusions include active hepatitis B or C infection, a history of serious mental illness, fluoxetine allergy, or inability to take oral medications.

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This is a phase I trial testing the safety and best dose of combining hypofractionated radiation therapy with bintrafusp alfa for advanced intrahepatic cholangiocarcinoma (bile duct cancer that has spread). The goal is to find a safe radiation dose and see if the combination can help control the cancer while identifying side effects. Eligible participants are adults with confirmed intrahepatic cholangiocarcinoma who have at least two measurable tumors (one to radiate and one accessible for biopsy) and who have had or refused standard chemotherapy. Researchers will look at response rates, progression-free and overall survival, and how biomarkers related to TGF-beta and the immune system relate to outcomes. Key exclusions include pregnancy, uncontrolled illness, active autoimmune disease, prior immune checkpoint inhibitors, recent cancer treatment, and untreated CNS metastases.

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Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies is being studied. Conditions: Ovarian Cancer, Breast Cancer, Pancreatic Cancer +10 • Eligibility: Key Inclusion Criteria: * Age ≥ 18 at the time of screening * Histological or cytological confirmation of advanced malignancy considered to be suitable for study treatment and…. Goal: This research is designed to determine if experimental treatment with PARP inhibitor, AZD5305, alone, or in combination with anti-cancer agents is safe, tolerable, and has anti-cancer activity in patients with advanced solid tumors. Phase/Status/Sponsor: Unknown phase; ACTIVE_NOT_RECRUITING; AstraZeneca.

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PErioperative CISGEM + Rilvegostomig in High-Risk Resectable Intra Hepatic CholangioCarcinoma is being studied. Conditions: Intrahepatic Cholangiocarcinoma (Icc) • Eligibility: Inclusion Criteria: 1. Age ≥ 18 years 2. WHO Performance Status 0-1 3. Body weight \> 30kg 4. Histo/cytologically proven intrahepatic cholangiocarcinoma. 5. Measurable disease as defined by…. Goal: The goal of this trial is to determine whether the combination of CISGEM and Rilvegostomig during the perioperative period works to improve outcomes of patient undergoing surgery of high-risk of intrahepatic cholangiocarcinoma Phase/Status/Sponsor: Unknown phase; NOT_YET_RECRUITING; Federation Francophone de Cancerologie Digestive.

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A Study to See the Effects That a New Combination of the Three Drugs, Nab-paclitaxel, Gemcitabine, and Cisplatin Has on Biliary Tract Cancer is being studied. Conditions: Unresectable Biliary Tract Cancer • Eligibility: Inclusion Criteria: 1. Histologically documented locally advanced or metastatic BTC (intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer, or ampullary carcinoma) not previously treated with palliative systemic therapy or radiation…. Goal: You are being asked to take part in this study because you have a biliary cancer that is incurable and has spread to other organs. Chemotherapy is often used to help shrink the cancer temporarily and may improve survival. Phase/Status/Sponsor: Unknown phase; ACTIVE_NOT_RECRUITING; AHS Cancer Control Alberta.

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- The trial tests whether Comprehensive Geriatric Assessment (CGA) with tailored perioperative care can reduce postoperative morbidity after major liver resection or pancreaticoduodenectomy for cancer in older adults. - It is for people aged 70 and older with hepatobiliary or pancreatic cancers who need these surgeries. - The study aims to learn if CGA can lower complications and improve quality of life after surgery. - Exclusions include not having access to the French health system, inability to consent, participation in a double-blind randomized trial, or being legally protected.

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The ANTARES study is testing whether nivolumab, a PD-1 blocker, can work in people with advanced or metastatic rare tumors that express PD-L1 (CPS ≥ 10), regardless of tumor type. It is a phase II basket trial, enrolling adults whose cancers have higher PD-L1 expression after standard treatments have failed. Treatment can last up to 12 months, and researchers will look at objective responses, progression-free survival, and biomarkers like PD-L1, ctDNA, and microvesicles. Exclusions include prior immunotherapy, pregnancy or breastfeeding, active infection, autoimmune disease (with limited exceptions), and uncontrolled CNS metastases, among other health criteria.

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Summary not available yet.

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Analysis of the Incidence of Cholangiocarcinoma on Choledochal Cyst in a Western Center is being studied. Conditions: Incidence of Cholangiocarcinoma on Choledochal Cysts, Postoperative Complications in Choledochal Cysts, Choledochal Cyst Monitoring • Eligibility: Inclusion Criteria: \- A radiological diagnosis (diagnosed by the radiology service) of choledochal cyst, understood as a dilatation of the extra or intrahepatic bile duct (fusiform or saccular,…. Goal: Choledochal cysts are congenital cystic dilatations of the intra and/or extrahepatic bile duct. They have been considered a rare entity of the child population. Phase/Status/Sponsor: Unknown phase; ENROLLING_BY_INVITATION; María Teresa Moreno Asencio.

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A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations is being studied. Conditions: Advanced Solid Tumors With HER2 Mutation,eg:Colorectal,Urothelial,Gastric, Hepatobiliary,Endometrial,Melanoma,Ovarian,Cervical,Salivary Gland,Pancreatic,Breast • Eligibility: Inclusion Criteria: * Adults ≥18 years old. Other age restrictions may apply as per local regulations. * Unresectable and/or metastatic solid tumors with pre-specified HER2 mutations (S310F, S310Y,…. Goal: This is an open-label, multi-center, single arm, Phase II study to evaluate the efficacy and safety of T-DXd for the treatment of unresectable and/or metastatic solid tumors harboring specific HER2 activating mutations regardless of tumor histology. The target population are patients who have progressed following prior treatment or who have no satisfactory alternative treatment options, including approved second line therapies in the specific tumor type. Phase/Status/Sponsor: Unknown phase; ACTIVE_NOT_RECRUITING; AstraZeneca.

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The trial tests Trilaciclib to protect the bone marrow from chemotherapy in people with advanced biliary tract cancer (cholangiocarcinoma) or pancreatic cancer. It is for adults 18 and older who need chemotherapy and have a confirmed diagnosis, with enough health and follow-up ability. The study aims to learn about Trilaciclib’s safety and whether it reduces chemotherapy-related bone marrow suppression. Major exclusions include history of certain myeloid blood disorders, active brain metastases, pregnancy or lactation, recent major surgery or radiotherapy, and known allergy to the study drug.

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Improving a Bile Duct Drainage Procedure in Patients With Inoperable Cancer Blocking the Bile Ducts: Comparing Two Types of Endoscopically Placed Internal Stents to Prevent Blockage of a Lumen Apposing Metal Stent is being studied. Conditions: Malignant Biliary Obstruction, Advanced Pancreatic Cancer and Cholangiocarcinoma, Inoperable Malignant Biliary Obstruction +1 • Eligibility: Inclusion Criteria: * Age ≥18 years. * Radiologically or histologically proven malignant distal bile duct obstruction with unresectable or metastatic disease, including those who have already failed ERCP…. Goal: This study looks at the best way to treat bile duct blockage in people with advanced cancer that cannot be removed by surgery. A blocked bile duct can cause serious symptoms like yellowing of the skin (jaundice), infection, and pain. Phase/Status/Sponsor: Unknown phase; NOT_YET_RECRUITING; Waikato Hospital.

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Summary not available yet.

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Testing A New Combination of Anti-cancer Immune Therapies, Atezolizumab and CDX-1127 (Varlilumab) With or Without the Addition of a Third Anti-cancer Drug, Cobimetinib, for Advanced-Stage Biliary Tract Cancer is being studied. Conditions: Metastatic Distal Bile Duct Adenocarcinoma, Metastatic Gallbladder Carcinoma, Metastatic Intrahepatic Cholangiocarcinoma +7 • Eligibility: Inclusion Criteria: * Pathologically confirmed biliary tract cancer, having received at least 1 prior line of systemic therapy, and received no more than 2 prior lines of therapy…. Goal: This phase II trial investigates the effect of combining two immune therapies, atezolizumab and CDX-1127 (varlilumab), with or without cobimetinib, in treating patients with biliary tract cancer that cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Phase/Status/Sponsor: Unknown phase; ACTIVE_NOT_RECRUITING; National Cancer Institute (NCI).

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Summary not available yet.

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- This observational study (MOROCCO) tests whether a blood test measuring PUMA levels can indicate treatment response and prognosis in cholangiocarcinoma. - It is for adults 18 years and older who have suspected or diagnosed cholangiocarcinoma and are being evaluated for curative surgical treatment. - Researchers will collect blood samples and review medical records to see if PUMA levels before and after neoadjuvant therapy and around surgery relate to treatment response, progression-free survival, and postoperative survival. - Key exclusions include metastatic disease beyond the bile ducts (except regional lymph nodes), recent other cancers or prior radiation/chemotherapy to the target area, prior transplantation, and current recurrence.

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- This is a nonrandomized, open-label, multicenter rollover study of futibatinib for patients who are still receiving the drug (monotherapy or in combination) and who are deriving clinical benefit with no undue risk. - It includes patients who previously received futibatinib in an antecedent Taiho-sponsored futibatinib study. - Participants must provide written informed consent, be able to take medications by mouth, and women of childbearing potential must have a negative pregnancy test; both men and women of reproductive potential must use effective birth control during treatment and for a specified time after the last dose. - A key exclusion is anyone who has met any discontinuation criteria within the antecedent futibatinib study. - Enrollment is by invitation.

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- The trial tests adjuvant therapy that combines tislelizumab (an immunotherapy) with capecitabine chemotherapy and radiotherapy after surgical removal of high-risk extrahepatic cholangiocarcinoma. - It is for adults who had resectable ECC, undergone radical surgery, are at high risk of recurrence (R0 with N1 or neurovascular invasion; or R1), and have not received prior systemic therapy. - The study aims to learn whether this treatment improves 2-year recurrence-free survival and to assess safety, enrolling about 65 participants. - Eligible participants are 18–70 years old with good performance status; key exclusions include active autoimmune disease requiring systemic therapy, HIV or active tuberculosis, recent thromboembolism, pregnancy, uncontrolled hypertension, and other cancers within the past 5 years.

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This is a Phase 1/2 trial testing TC-510, a novel autologous engineered T cell therapy, in adults with advanced cancers that express mesothelin. TC-510 uses T cells modified with a mesothelin-targeting single-domain antibody fused to CD3 and a PD-1:CD28 switch receptor to boost activity against PD-L1–positive cancer cells. Eligible cancers include malignant pleural mesothelioma, serous ovarian adenocarcinoma, pancreatic adenocarcinoma, triple-negative breast cancer, and colorectal cancer, as long as the tumor shows mesothelin expression by immunohistochemistry. Participants must be 18 or older, have 1–5 prior systemic therapies for metastatic or unresectable disease, a good performance status (ECOG 0–1), be fit for leukapheresis, and have adequate organ function; key exclusions are inability to follow study procedures and known non-compliance or drug/alcohol use.

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Hepatocellular Carcinoma 3 Gene Methylation Combination Detection Kit (PCR Fluorescent Probe Method) Multicenter Clinical Trial is being studied. Conditions: Hepatocellular Carcinoma (HCC) • Eligibility: Inclusion Criteria: 1. Age 18 years or older, gender unlimited; 2. Subjects for whom sufficient blood samples can be obtained (whole blood volume not less than 10 mL);…. Goal: This clinical trial aims to systematically evaluate the clinical performance and accuracy of the HepaAiQ test kit, a multi-gene methylation assay based on PCR with fluorescent probe detection. The test results are compared against clinical reference standards, including pathological and/or imaging diagnoses, to assess the product's diagnostic performance. Phase/Status/Sponsor: Unknown phase; ACTIVE_NOT_RECRUITING; Singlera Genomics Inc..

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This expanded access program provides ulixertinib (BVD-523) for compassionate use in people with advanced MAPK pathway–altered solid tumors (including KRAS, NRAS, HRAS, BRAF, MEK, and ERK mutations). It is for patients aged 12 and older who have exhausted or not adequately benefited from standard cancer therapies, and it may be given alone or with other tolerable drugs. The goal is to make ULIXERTINIB available and monitor safety and how well patients tolerate it in real-world use. Key exclusions include currently being enrolled in another ulixertinib trial, recent systemic therapy or radiotherapy within defined windows, history of retinal vein occlusion or central serous retinopathy, pregnancy or breastfeeding, significant uncontrolled illness, prior stomach/duodenal surgery affecting absorption, and use of certain interacting medications (strong inhibitors/inducers of CYP1A2, CYP2D6, or CYP3A4).

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- The trial tests peposertib together with avelumab and hypofractionated radiation therapy in adults with advanced or metastatic solid tumors and hepatobiliary cancers. - It aims to find a safe dose and assess how well this combination works, with Phase II focusing on hepatobiliary tumors and comparing against avelumab plus radiation alone by measuring objective response rate. - The study will also look at how the drugs are processed in the body and collect biomarker data to understand who may respond. - Eligibility notes include that Phase I excludes prior immune checkpoint therapy, while Phase II has some allowed prior checkpoint exposure under specific conditions; pregnancy is not allowed and certain autoimmune or CNS conditions exclude participation. - The study status is currently suspended.

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Early Access Program Providing HER2/HER3 Bispecific Antibody, MCLA-128, for a Patient With Advanced NRG1-Fusion Positive Solid Tumor is being studied. Conditions: NRG1 Fusion, Pancreatic Cancer, Non Small Cell Lung Cancer +8 • Eligibility: Inclusion Criteria: * Age 18 years or older * At least one evaluable or measurable lesion according to RECIST v1.1 * Patient with advanced metastatic solid tumor with…. Goal: Merus is providing single patient/named access to the HER2/HER3 bispecific antibody, MCLA-128, to patients with advanced NRG1-fusion positive solid tumor under this early access program who are ineligible for an ongoing MCLA-128 clinical trial or have other considerations that prevent access to MCLA-128 through an existing clinical trial. Participating sites will be added as they apply for and are approved for the EAP. Phase/Status/Sponsor: Unknown phase; APPROVED_FOR_MARKETING; Merus B.V..

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This study tests an oral drug called AG-120 (ivosidenib) in people with IDH1-mutated advanced solid tumors, including glioma. It enrolls adults whose disease has recurred or progressed after standard therapy and includes several expansion groups such as cholangiocarcinoma, chondrosarcoma, non-enhancing glioma, and other IDH1-mutated tumors. The study first uses a dose-escalation phase to find the maximum tolerated dose and a recommended Phase II dose, then expands at that dose to evaluate safety, tolerability, and any signs of clinical activity. The trial aims to learn how safe the drug is, how it behaves in the body, and whether it shows anticancer activity at the chosen dose. Key exclusions include recent anticancer therapy or investigational agents, certain heart conditions or QT prolongation risk, pregnancy, and untreated or recently treated brain metastases.

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- The study tested the [18F]FAPI-74 PET scan to detect FAP-expressing cells in people with gastrointestinal cancers, including liver cancer, cholangiocarcinoma, gastric, pancreatic, and colorectal cancer. - It enrolled adults with confirmed GI cancers and used the PET scan after initial staging, comparing PET results with FAP immunohistochemistry as the primary objective and with histopathology as the secondary objective. - Participants needed a tissue sample from biopsy or planned biopsy/resection, no cancer treatment between tissue sampling and the PET scan, and informed consent. - Exclusions included pregnancy or breastfeeding, infections or serious illnesses that could affect FAP expression, recent use of another investigational agent, and known hypersensitivity to components of the tracer. - The study is completed.

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Pilot Study to Determine Pro-Inflammatory Cytokine Kinetics During Immune Checkpoint Inhibitor Therapy is being studied. Conditions: Melanoma, Gastrointestinal Neoplasms, Genitourinary Cancer +2 • Eligibility: Inclusion Criteria: 1. ≥ 18 years old at the time of informed consent 2. Diagnosed with non-small cell lung cancer (NSCLC) OR melanoma AND initiating therapy with single…. Goal: This research aims to identify clinical strategies to manage adverse events during immune checkpoint inhibitor therapy by (1) determining the impact of checkpoint inhibitors on metabolism through major CYP enzymes and (2) identifying associations between pro-inflammatory cytokine concentrations and negative clinical outcomes during checkpoint inhibitor therapy. Phase/Status/Sponsor: Unknown phase; COMPLETED; Indiana University.

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- This trial tested whether adding hepatic arterial infusion chemotherapy with oxaliplatin and 5-fluorouracil to biliary drainage improves survival for people with locally advanced, unresectable perihilar cholangiocarcinoma (pCCA). - It compared biliary drainage plus this chemotherapy approach against biliary drainage plus best supportive care. - Participants were adults aged 18–80 with locally advanced unresectable pCCA, good performance status, and adequate liver function; key exclusions included allergy to contrast or 5-FU, pregnancy, prior chemotherapy or radiotherapy, metastases, and serious comorbidities. - The study has completed and aimed to determine whether the combined treatment provides a survival benefit and acceptable safety.

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Clinical Utility of Selected Circulating Tumor DNA Assays in Patients With Advanced Malignancy is being studied. Conditions: Metastatic Colorectal Cancer, Pancreas Adenocarcinoma, Cholangiocarcinoma • Eligibility: Inclusion Criteria: Newly referred patients with advanced pancreatic cancer (\~20/year), Cholangiocarcinoma (\~20/year), metastatic colorectal cancer (mCRC) (\~50/year) and anti-EGFR-treated mCRC patients (\~10/year) to Oslo University Hospital are eligible…. Goal: Circulating tumor DNA assays are becoming relevant for routine diagnostics, but many related aspects are yet unresolved. With this project, the investigators aim to develop pragmatic molecular diagnostic pathways of liquid biopsies relevant in advanced gastrointestinal malignancies with focus on clinical utility and sensible use of resources. Phase/Status/Sponsor: Unknown phase; TERMINATED; Oslo University Hospital.

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- This study tested bemarituzumab in adults whose solid tumors overexpress FGFR2b. - It aimed to assess safety and tolerability and to look for early signs of anti-tumor activity. - Eligible participants had unresectable, locally advanced, or metastatic cancers (such as head and neck squamous cell carcinoma, triple-negative breast cancer, intrahepatic cholangiocarcinoma, lung adenocarcinoma, platinum-resistant ovarian cancer, endometrial or cervical cancer, or other solid tumors) with FGFR2b overexpression and prior therapy. - Exclusions included untreated or symptomatic CNS metastases, certain heart and eye conditions, and prior investigational FGFR pathway inhibitors. - The study status is completed.

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A Study Evaluating Different Doses of BI 765049 When Given Alone and When Given With Ezabenlimab to Patients With Advanced Solid Tumors Expressing the Protein B7-H6 on the Cell Surface is being studied. Conditions: Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Pancreatic Neoplasms, Carcinoma, Hepatocellular, Head and Neck Neoplasms, Gastrointestinal Neoplasms • Eligibility: Inclusion Criteria: * Signed and dated, written informed consent form (ICF) (ICF1 for B7-H6 testing for all patients except those with advanced or metastatic colorectal cancer (CRC); and…. Goal: This study is open to adults with advanced solid tumors whose previous cancer treatment was not successful. People can participate if their tumor has the B7-H6 marker or if they have colorectal cancer. Phase/Status/Sponsor: Unknown phase; COMPLETED; Boehringer Ingelheim.

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Diagnostic Efficacy of EUS-FNA/B Versus ERCP With or Without POCS-TB in Patients With Suspected Hilar Cholangiocarcinoma is being studied. Conditions: Klatskin Tumor, Cholangiocarcinoma, Biopsy, Fine-Needle +1 • Eligibility: Inclusion Criteria: 1. ≥ 18 years old; 2. Newly diagnosed patients with suspected hilar cholangiocarcinoma on imaging examination Exclusion Criteria: 1. Patients with a definite diagnosis of cholangiocarcinoma…. Goal: This is an observational study with a prospective cohort design. This study enrolled patients with suspected hilar cholangiocarcinoma on imaging. Phase/Status/Sponsor: Unknown phase; COMPLETED; Qilu Hospital of Shandong University.

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The Brightline-2 trial tests whether brigimadlin (BI 907828) helps adults with advanced cancer of the biliary tract, pancreas, lung, or bladder. It’s for people whose cancer has not responded to standard treatment or for whom no standard treatment exists. Brigimadlin is taken as a tablet every 3 weeks, with regular visits to monitor tumor size and safety. Eligibility requires specific tumor biology (MDM2 amplification or TP53 wild-type) confirmed by tissue testing and measurable disease with good performance status. Key exclusions include prior brigimadlin or other MDM2/MDMX-p53 drugs, risk of significant bleeding, or conditions that could make participation unsafe. The study is completed.

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HAIC Combined With Donafenib and Sintilimab for Unresectable ICC is being studied. Conditions: Cholangiocarcinoma • Eligibility: Inclusion Criteria: * Unresectable or metastatic histologically or cytologically confirmed ICC * No previous systemic treatment or local anti-tumor treatment other than surgery (biliary drainage is allowed), admission…. Goal: To evaluate the safety and tolerability of HAIC combined with donafenib and sintilimab in first-line treatment of unresectable ICC. Phase/Status/Sponsor: Unknown phase; COMPLETED; Zhongda Hospital.

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The study tests whether people with advanced solid tumors who have stable disease can stop PD-1/PD-L1 treatment after one year without harming outcomes. It is for patients being treated with PD-1/PD-L1 drugs (like pembrolizumab, nivolumab, atezolizumab, durvalumab, or avelumab). Participants are randomly assigned to stop treatment after about one year or continue treatment until the cancer progresses, to learn the best length of therapy. To join, patients must have at least stable disease on scans within six weeks of randomization; those with progressive disease before randomization or immune-related toxicity that prevents staying on therapy beyond one year are excluded.

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BMS-986156, Ipilimumab, and Nivolumab With or Without Stereotactic Body Radiation Therapy in Treating Patients With Advanced or Metastatic Lung/Chest or Liver Cancers is being studied. Conditions: Advanced Malignant Solid Neoplasm, Metastatic Carcinoma in the Liver, Metastatic Carcinoma in the Lung +2 • Eligibility: Inclusion Criteria: * Patients must have histological confirmation of solid metastatic cancer with at least one metastatic or primary lesion in the liver or lung/chest, except for group…. Goal: This phase I/II trial studies the side effects and best dose of anti-glucocorticoid-induced tumor necrosis factor receptor (GITR) agonistic monoclonal antibody BMS-986156 (BMS-986156) when given together with ipilimumab and nivolumab with or without stereotactic body radiation therapy and to see how well they work in treating patients with lung/chest or liver cancer that has spread to other places in the body. Immunotherapy with monoclonal antibodies, such as BMS-986156, ipilimumab, and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Phase/Status/Sponsor: Unknown phase; COMPLETED; M.D. Anderson Cancer Center.

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This trial tests ZW25 (zanidatamab) added to standard first-line chemotherapy in people with HER2-expressing gastrointestinal cancers that are unresectable or metastatic, specifically gastroesophageal adenocarcinoma, biliary tract cancer, or colorectal cancer. The study has two parts: Part 1 checks safety and tolerability and helps establish a recommended dose for the combination, and Part 2 evaluates the anti-tumor activity. Eligible participants have HER2-expressing tumors, are unresectable or metastatic, and have good performance status with adequate organ and heart function; colorectal cancer participants must have wild-type RAS/BRAF, with additional biomarker criteria by part. Key exclusions include prior HER2-targeted therapy, recent systemic cancer treatment (with limited exceptions), untreated brain metastases, significant cardiac disease, QTc prolongation, active infections, or uncontrolled HIV/HBV/HCV.

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This completed trial tested whether colchicine can provide palliative benefits and potentially improve survival for people with primary liver cancers that cannot be cured. It enrolled adults with primary hepatic malignancies (such as hepatocellular carcinoma or intrahepatic cholangiocarcinoma) who could not have curative treatment. Colchicine was given in cycles, starting at 2 mg per day in divided doses, with dose adjustments based on liver function and tolerance, in a 4 days-on, 3 days-off pattern. Key exclusions included life-threatening hemorrhage or infection, kidney dysfunction (creatinine >1.5 mg/dL), very low blood counts, pregnancy, allergy to colchicine, prior systemic chemotherapy within 2 months, or participation in another trial.

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This study tested whether tumor tissue and blood can identify biomarkers that predict how advanced biliary tract cancer responds to a chemotherapy combination of gemcitabine, cisplatin, and nab-paclitaxel. It enrolled adults with biliary tract cancer that is unresectable, metastatic, or recurrent, who planned to receive the triplet chemotherapy after tumor sequencing. Researchers used biopsy samples for in-house sequencing and collected blood over time to study cell-free DNA and circulating tumor cells and their relation to response and progression. Eligibility required measurable disease and good performance status, with key exclusions including uncontrolled illness, prior palliative chemotherapy for BTC, and dementia or other conditions affecting consent. Status: COMPLETED; Sponsor: CHA University; Phase: Unknown.

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Treatment Strategy for Adult Congenital Biliary Dilation is being studied. Conditions: Congenital Biliary Dilation • Eligibility: Inclusion Criteria ： 1. Age: Adults (≥18 years). 2. Study population: Consecutive patients treated at Beijing Tsinghua Changgung Hospital. 3. Time frame: Underwent surgical treatment between November 2014…. Goal: The management of congenital biliary dilations (CBDs), including choledochal cysts, represents one of the most challenging areas in hepatobiliary surgery due to their potential implications for long-term morbidity and malignant transformation. While CBDs have a relatively low incidence in Western populations (1/150,000-1/100,000), the prevalence is notably higher in Asian countries (1/1,000), making it a significant global health concern. Phase/Status/Sponsor: Unknown phase; COMPLETED; Beijing Tsinghua Chang Gung Hospital.

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Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types is being studied. Conditions: Bile Duct Cancer, Gall Bladder Cancer, Breast Cancer +6 • Eligibility: Inclusion Criteria: * Subjects must have had at least one prior treatment with systemic therapy for advanced and unresectable, or metastatic disease OR is intolerant to, has refused…. Goal: Checkpoint inhibitor therapy represents a significant advance in cancer care. The interaction between PD-1 and PD-L1 induces immune tolerance, and the inhibition of this interaction is an effective treatment strategy for numerous malignancies. Phase/Status/Sponsor: Unknown phase; SUSPENDED; University of Florida.

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Skeletal Muscle Energy Metabolism in Undernourished Patients With Gastrointestinal Cancer is being studied. Conditions: Undernutrition, Gastrointestinal Cancer • Eligibility: Case group selection criteria: Inclusion Criteria: * 18 years ≤ Age ≤ 80 years * Colorectal pancreatic cancer * Undernutrition related to cancer (weight loss \> 5% weight…. Goal: Undernutrition associated with cancer, or cancer cachexia results from a deterioration of the energy balance that leads to a gradual mobilization of energy reserves in the body and to increasing deterioration of the nutritional status of patients. This will thus significantly reduce quality of life and survival of patients with a lower tolerance to cancer treatments. Phase/Status/Sponsor: Unknown phase; COMPLETED; University Hospital, Tours.

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- The Liver and Biliary Tumor Tissue Registry collects tissue from adults having surgery to remove a liver or biliary mass or from those having a biopsy, to store for future research. - A blood sample may also be collected at enrollment. - The goal is to support translational research on the biology, causes, and prognosis of liver and biliary diseases, including studies that may use patient-derived xenografts. - Eligibility: people scheduled for surgical resection of a liver or biliary mass; Exclusions: under 18 years old or prior radiation to the mass. - Status: terminated.

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- The study tested ABC294640 alone and in combination with hydroxychloroquine sulfate (HCQ) in adults with unresectable cholangiocarcinoma. - Part 1 gave ABC294640 (500 mg twice daily); Part 2 added HCQ with a dose-escalation plan to find a safe, tolerable HCQ dose. - The trial aimed to learn whether these drugs have activity against cholangiocarcinoma and to assess safety, tolerability, and tumor response over time. - Eligible participants were adults with unresectable disease and up to two prior systemic therapies; key exclusions included prior ABC294640 or HCQ for cancer, active infections or significant cardiac disease, pregnancy, HIV, and certain anticoagulant use.

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This is a non-interventional registry study in France to collect data on the use of TheraSphere for liver cancers. It includes people with hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma (iCC), or liver metastases from colon cancer who have received a reimbursed dose of TheraSphere. The study aims to learn how effective TheraSphere is in real-world practice, including safety, quality of life, and survival, and to support reimbursement claims in France. Eligibility requires consent to collect medical data and having received a reimbursed dose; exclusions are opposing data collection or not having received a reimbursed dose. Status: COMPLETED.

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This study tested a non-invasive liquid biopsy panel (exo-miRNAs) to detect lymph node metastasis before treatment in intrahepatic cholangiocarcinoma (ICC) patients. It enrolled people with a histologically confirmed ICC who had at least one pre-treatment blood sample available. The goal was to see if the biomarker panel can accurately predict LNM before surgery, to help guide treatment decisions. The study is completed and excluded participants who could not consent, had synchronous non-ICC liver cancer diagnosed at or before surgery, or had secondary liver cancer.

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- The trial tested the safety and early anti-cancer activity of a three-drug combo—ivosidenib with nivolumab and ipilimumab—in adults with nonresectable or metastatic IDH1-mutant cholangiocarcinoma. - It started with a safety lead-in to find the recommended combination dose and planned a dose-expansion to assess efficacy, but the expansion was never started because the study was terminated. - Eligibility required adults 18 or older with IDH1-mutant cholangiocarcinoma, ECOG 0–1, at least one measurable tumor, and nonresectable/metastatic disease not eligible for curative therapy (prior local therapy allowed under certain conditions). - Key exclusions included prior IDH inhibitors or prior immune checkpoint inhibitors other than anti-PD-1/PD-L1, active autoimmune disease or systemic immunosuppression, unresolved toxicity from prior therapy, and symptomatic brain metastases requiring steroids.

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This study tested NXP800, a drug that blocks the heat shock factor 1 pathway, in adults with advanced or metastatic biliary tract cancer, including cholangiocarcinoma. Its goals were to find the maximum tolerated dose and the recommended dose for later study, and to evaluate safety, tumor response, and survival. Researchers planned to collect biomarker data (RNA sequencing, genome sequencing, and ctDNA) to learn why tumors respond or become resistant. Key exclusions include pregnancy or nursing, uncontrolled heart failure or brain metastases, recent cancer treatments or major surgery, and certain drug interactions or grapefruit products. The trial status is terminated.

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- This completed study tested a pre-surgery chemotherapy combination (gemcitabine, cisplatin, and nab-paclitaxel) for people with high-risk intrahepatic cholangiocarcinoma, a liver bile duct cancer, who are eligible for surgery. - It looks to see if this neoadjuvant treatment can shrink the tumor enough to allow complete surgical removal. - The trial measured how the tumors responded on imaging, the rate of R0 (clear margin) surgeries, and longer-term outcomes like recurrence-free and overall survival. - Eligible participants are adults with high-risk but resectable disease confined to the liver, with good organ function and no distant metastases; key exclusions include significant neuropathy, uncontrolled medical conditions, pregnancy, CNS disease, and recent other cancers.

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Study of DKN-01 and Gemcitabine/Cisplatin in Patients With Carcinoma to Primary to the Intra- or Extra-Hepatic Biliary System or Gallbladder is being studied. Conditions: Carcinoma of Intrahepatic and Extra-hepatic Biliary System, Carcinoma of Gallbladder, Bile Duct Cancer +1 • Eligibility: Inclusion Criteria: 1. Patient has carcinoma primary to the intra- or extra-hepatic biliary system or gall bladder. 2. Patient must have sufficient tumor tissue available for submission. 3.…. Goal: DKN-01 is a humanized monoclonal antibody (Mab) with neutralizing activity against Dkk-1 and is being developed as an anti-neoplastic agent. This study is designed to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of DKN-01 in combination with gemcitabine and cisplatin in patients with carcinoma primary to the intra- or exta-hepatic biliary system or gallbladder. Phase/Status/Sponsor: Unknown phase; COMPLETED; Leap Therapeutics, Inc..

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