Hepatocellular carcinoma (HCC) 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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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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- The trial tests Sapu003 in adults with advanced mTOR-sensitive solid tumors, in two groups: Cohort A will receive Sapu003 with exemestane for HR+/HER2-negative breast cancer, and Cohort B will receive Sapu003 alone for RCC, NETs, TSC-associated tumors, or HCC. - This is a phase 1b, open-label, dose-escalation study to find the maximum tolerated dose and to assess safety, pharmacokinetics, and any early antitumor activity. - Eligibility includes adults 18 years or older with the specified cancers, ECOG 0–2, and adequate organ function; key exclusions include active brain metastases, uncontrolled infections or other serious conditions, HIV/HBV/HCV infection, recent major surgery, and pregnancy or breastfeeding. - Sapu003 will be given as weekly IV infusions at 5, 7.5, or 10 mg/m2 in 28-day cycles.

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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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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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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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- 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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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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A Study to Assess the Long-term Safety Outcomes in Patients Previously Treated With RP1, RP2, or RP3 is being studied. Conditions: Melanoma, Metastatic Melanoma, Advanced Solid Tumor +1 • Eligibility: Inclusion Criteria: Patients are eligible for inclusion in the study only if they meet all of the following criteria: 1. Patient has received at least 1 dose of…. Goal: This is a noninterventional, observational, long-term follow-up (LTFU) study. Patients in this study will be followed for 5 years from enrollment on this study to assess potential delayed risks of RPx products. Phase/Status/Sponsor: Unknown phase; RECRUITING; Replimune Inc..

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A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing is being studied. Conditions: Locally Advanced Alveolar Soft Part Sarcoma, Metastatic Alveolar Soft Part Sarcoma, Locally Advanced Non Small Cell Lung Cancer +7 • Eligibility: * INCLUSION CRITERIA: * Participants with a locally advanced or metastatic pathologically confirmed cancer whose NCI Licensed Independent Practitioner (LIP) determined they are candidates for treatment with atezolizumab,…. Goal: Background: A type of drug called monoclonal antibody immune checkpoint inhibitors are often used in cancer treatment. These drugs help the body s immune system fight cancer by blocking proteins that cause cancer cells to grow. Phase/Status/Sponsor: Unknown phase; RECRUITING; National Cancer Institute (NCI).

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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 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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[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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- 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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Intravital Microscopy in Human Solid Tumors is being studied. Conditions: Solid Tumor, Adult, Clinical Stage IV Gastric Cancer AJCC v8, Malignant Solid Neoplasm +20 • Eligibility: Inclusion Criteria: * Age ≥ 18 years of age * Eastern Cooperative Oncology Group (ECOG)Performance Status of ≤ 2 * Measurable tumor by direct visualization requiring surgical resection…. Goal: This study will investigate the tumor-associated vasculature of patients with solid tumors. The investigators will use a technology known as intravital microscopy (IVM) in order to visualize in real-time the vessels associated with solid tumors. Phase/Status/Sponsor: Unknown phase; RECRUITING; Mayo Clinic.

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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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- 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 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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- 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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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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A Beta-only IL-2 ImmunoTherapY Study is being studied. Conditions: Advanced Solid Tumor, Unresectable Solid Tumor, Clear Cell Renal Cell Carcinoma +34 • Eligibility: Key Inclusion Criteria: 1. Aged at least 18 years (inclusive at the time of informed consent). 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.…. Goal: This is a Phase 1/2, multi-center, open-label, dose-escalation and expansion study to evaluate safety and tolerability, PK, pharmacodynamic, and early signal of anti-tumor activity of MDNA11 alone or in combination with a checkpoint inhibitor in patients with advanced solid tumors. Phase/Status/Sponsor: Unknown phase; RECRUITING; Medicenna Therapeutics, Inc..

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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 multicenter, randomized, open-label trial tests whether adding prophylactic cholecystectomy to primary tumor surgery for midgut neuroendocrine tumors reduces biliary stone disease two years after surgery. - It is for adults with midgut NETs (jejunum, ileum, or proximal colon) who need primary tumor resection, with or without gallstones at baseline. - Participants are randomly assigned to either primary tumor resection alone or primary tumor resection plus prophylactic cholecystectomy and followed for 104 weeks (2 years). - The main goal is to measure the cumulated incidence rate of biliary stone disease after surgery. - Key exclusions include prior bowel resection or prior cholecystectomy, existing biliary stone disease, tumors outside the specified gut locations, and certain liver or gallbladder conditions that could affect safety or eligibility.

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City of Hope Medical Center is conducting a recruiting trial that tests an exosome-based liquid biopsy to distinguish hepatocellular carcinoma (HCC) from intrahepatic cholangiocarcinoma (ICC). The test analyzes exosomal microRNAs in blood and uses machine learning to create a differential diagnosis panel. The goal is a noninvasive, cost-efficient test with high accuracy to guide treatment decisions before surgery. Eligible participants must have a histologically confirmed HCC or ICC and provide a pre-treatment blood sample; key exclusions include inability to consent, having both HCC and ICC, other primary liver cancers, or secondary liver cancer.

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This is a pilot study testing whether combining immunotherapy with stereotactic body radiotherapy (SBRT) can shrink unresectable hepatocellular carcinoma (HCC) enough to make surgery possible. It targets adults with HCC that cannot be removed by surgery, including patients with up to three lesions or segmental portal vein involvement, who have relatively preserved liver function and good performance status. The study aims to learn if this downstaging approach allows resection and improves outcomes for HCC patients. Exclusions include prior invasive cancer or prior liver radiotherapy, severe other illnesses, extrahepatic metastases, major vessel thrombosis, ascites or encephalopathy, and SBRT contraindications such as very large tumors (any >15 cm or total tumor sum >25 cm), more than three nodules, or direct extension into the GI tract.

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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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CisPlatin plUs Gemcitabine and Nabpaclitaxel (GAP) as pReoperative Chemotherapy Versus Immediate Resection in patIents With resecTable BiliarY Tract Cancers (BTC) at High Risk for Recurrence is being studied. Conditions: Biliary Tract Cancer, Cholangiocarcinoma • Eligibility: Inclusion Criteria: 1. Patient able and willing to provide written informed consent and to comply with the study protocol and with the planned surgical procedures. 2. Female and…. Goal: PURITY is a multicentre, randomized adaptive phase II/III trial aimed at comparing the triplet combination of gemcitabine, cisplatin and nabpaclitaxel as neoadjuvant treatment (ARM A) versus standard upfront surgery (ARM B) in terms of 12-month PFS rate (phase II part) and PFS (phase III part) in patients with resectable BTC at high risk for recurrence. Phase/Status/Sponsor: Unknown phase; RECRUITING; Gruppo Oncologico del Nord-Ovest.

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Summary not available yet. The trial tests using locoregional radiotherapy (SBRT or Y90) followed by the immunotherapy AtezoBev to treat advanced hepatocellular carcinoma with macrovascular invasion before liver transplantation. It’s for adults 18–70 with HCC that has macrovascular invasion, no extrahepatic disease, and acceptable liver function and tumor burden, who are being evaluated for liver transplant (including criteria like Child-Pugh A-B7, ECOG 0–1, tumor volume under 350 cm3, and AFP under 5000 ng/mL). The study aims to see how many patients can be downstaged to transplant eligibility and actually receive a liver transplant, plus 5-year overall survival and recurrence-free survival after transplant; it also tracks radiologic, pathologic, and biochemical responses. Key exclusions include poorly differentiated HCC, portal vein tumor thrombus extending beyond the main portal vein, BMI ≥ 40, prior HCC therapy other than resection/ablation, and contraindications to radiotherapy or AtezoBev, or presence of extrahepatic disease.

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This trial tests the safety, tolerability, efficacy, and immune response of RZ-001 given with Valganciclovir and Atezolizumab/Bevacizumab in people with hTERT-positive hepatocellular carcinoma. It targets adults with HCC at BCLC stage B or C who are ECOG 0–1, have Child-Pugh A liver function, and a life expectancy of at least 3 months. Fifteen subjects are planned for each of three cohorts, with a Safety and Efficacy Review Committee meeting after about Day 43 to decide dose escalation. Exclusions include moderate or severe ascites, hepatic encephalopathy, cancers other than HCC, current or past HIV infection, or other factors the investigator deems unsuitable.

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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 post-marketing surveillance study in Japan is testing the safety of IMJUDO in combination with IMFINZI or IMFINZI alone for unresectable hepatocellular carcinoma (HCC). It includes patients who are treated in real-world clinical practice with these therapies for unresectable HCC. The study aims to collect safety information as part of the Japan Risk Management Plan and to support regulatory reexamination under Japanese law. Eligibility: All patients who receive IMJUDO plus IMFINZI combination therapy or IMFINZI monotherapy for unresectable HCC; no exclusion criteria are listed in the provided information. The study is currently recruiting and sponsored by AstraZeneca.

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Liver Cancer Registry Platform is being studied. Conditions: Hepatocellular Carcinoma (HCC), Cholangiocarcinoma • Eligibility: Inclusion criteria: * Confirmed hepatocellular carcinoma (HCC) or cholangiocarcinoma (CCC) als early, intermediate or advanced/metastatic stage * Age ≥ 18 years * Signed and dated informed consent (IC):…. Goal: The purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study with associated satellites, a tumor registry platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with Hepatocellular Carcinoma (HCC) or Cholangiocarcinoma (CCC) in Germany. Phase/Status/Sponsor: Unknown phase; RECRUITING; iOMEDICO AG.

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- This trial tests the safety of delivering nab-paclitaxel directly into the abdomen with pressurized intraperitoneal aerosolization (PIPAC) together with gemcitabine and cisplatin for biliary tract cancers that have spread to the peritoneum. - It is for adults with biliary tract cancer and visible peritoneal metastases who meet health criteria. - The study aims to learn about safety and how well the treatment works, including overall survival, progression-free survival, surgical outcomes after the PIPAC procedure, and patients’ quality of life and daily functioning. - Key exclusions include prior systemic therapy for advanced disease, substantial liver involvement, brain metastases, pregnancy, and other serious health conditions.

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The ROWAN trial tests whether giving TheraSphere (radioembolization) before durvalumab and tremelimumab can help control liver tumors in people with hepatocellular carcinoma (HCC). It is a global, open-label Phase II study for adults who are not candidates for liver resection, thermal ablation, or liver transplant. The study aims to learn about safety and whether this sequence improves local tumor control and overall outcomes. Key eligibility notes: participants must have HCC with adequate liver function and performance status; there are exclusions for extrahepatic metastases, active autoimmune disease, prior systemic HCC therapy, active infections, pregnancy, and other safety concerns. The trial is currently active but not recruiting.

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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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Early-stage Detection of LIver, Biliary TRAct and PancReatic Cancers is being studied. Conditions: Liver Cancer, Biliary Tract Cancer, Pancreatic Cancer • Eligibility: Criteria: Inclusion Criteria for Cancer Arm Participants: Age 40-75 years at the day of consenting to the study. Able to provide a written informed consent. Pathologically confirmed liver,…. Goal: LIBRARY is a prospective, multi-center, observational study aimed at detecting early liver, biliary tract, and pancreatic cancers by combining assays of cell-free DNA (cfDNA) methylation, serum protein, and microRNA. Phase/Status/Sponsor: Unknown phase; RECRUITING; Second Affiliated Hospital, School of Medicine, Zhejiang University.

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The BOMASH study is testing whether researchers can identify biomarkers and other factors that predict outcomes for people with MASLD/MASH, including the risk of needing a liver transplant or developing hepatocellular carcinoma (HCC). It is a single-center, observational study with no drug interventions, and it includes adults diagnosed with MASLD/MASH. The goal is to learn prognostic factors and non-invasive tests that can help risk-stratify patients and guide future care. There are no formal exclusion criteria listed for participation.

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The LIVELONG trial tests whether adding locally ablative therapies to ongoing systemic cancer treatment benefits people with oligo-progressive gastrointestinal cancers. It includes adults with gastric/GEJ, small bowel, colorectal/appendiceal, biliary, hepatocellular carcinoma, or pancreatic/ampullary cancers who have up to five new or progressing metastases and can continue systemic therapy with at most a 30-day break for ablation. Participants will receive either stereotactic ablative radiotherapy or interventional radiology ablation in addition to their current systemic therapy, and will be followed to assess disease control at 3 months and time to treatment failure. The trial is a single-site, pragmatic phase 2 study at UC Davis; key exclusions include medical conditions that preclude ablative therapy, prior toxicities that would prohibit ablation, and progressing brain 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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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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Microbiota Modification for Immuno-oncology in Hepatocellular Carcinoma is being studied. Conditions: Hepatocellular Carcinoma • Eligibility: Inclusion Criteria: 1. Male and Female 2. Age ≥18 years at time of signing informed consent 3. Presenting with HCC, diagnosed either by histological or radiological criteria as…. Goal: Hepatocellular carcinoma (HCC) is the most common liver primary cancer with a high rate of mortality. Since the results of IMbrave150, immunotherapy have emerged as a standard of care for HCC patients advanced and/or unresectable in first line of treatment. Phase/Status/Sponsor: Unknown phase; RECRUITING; Center Eugene Marquis.

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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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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 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 trial tests whether ondansetron can reduce immune checkpoint inhibitor–related toxicities in people with hepatocellular carcinoma who will receive standard ICI therapy. It is a randomized, single-center study planned to enroll 66 adults aged 18 to 80. The study will use the 2023 CSCO guidelines and will measure how often and how severe immune-related adverse events are to see if ondansetron improves safety. Key exclusions include autoimmune diseases, recent use of systemic steroids or immunosuppressants, prior ICI discontinuation due to irAEs, severe liver dysfunction, and contraindications or allergies to ondansetron or related drug interactions. Status is not yet recruiting; sponsor is the First Affiliated Hospital of Wenzhou Medical University.

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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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- The study tests a combination therapy of Gecacitinib (a JAK inhibitor) with Donafenib and a PD-1 inhibitor for unresectable hepatocellular carcinoma. - It aims to evaluate safety and efficacy, with objective response rate as the primary outcome and overall survival, progression-free survival, disease control rate, and safety as secondary outcomes. - Eligible participants are adults aged 18–75 with unresectable HCC that has measurable tumors, a good performance status (ECOG 0–1), and Child-Pugh ≤7 liver function. - Key exclusions include fibrolamellar, sarcomatoid, or cholangiocarcinoma subtypes, diffuse tumors, certain severe liver conditions, prior JAK inhibitor use, and recent or life-threatening bleeding.

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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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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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Theranostic Approach by Early Multigene Sequencing in Advanced Poor Prognosis Cancers is being studied. Conditions: Breast Cancer, Liver Cancer, Pancreatic Ductal Adenocarcinoma • Eligibility: Inclusion Criteria: * \- Age \>18 years. * Advanced disease status ("unresectable" or "metastatic"). * Patient included either at the time of diagnostic investigation or during first line…. Goal: The European Society for Medical Oncology (ESMO) strongly recommends to develop multigene sequencing in the framework of molecular screening programmes, in order to improve access to innovative drugs and to accelerate clinical research in cancers. * Accordingly, this project aims to study the contribution of early systematic multigene sequencing (NGS) discussed in Molecular Tumour Board for poor prognosis cancers, with no current indication for early sequencing. Phase/Status/Sponsor: Unknown phase; NOT_YET_RECRUITING; University Hospital, Lille.

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D07001 Softgel-Capsules and Capecitabine Combination Therapy in Patients With Advanced Biliary Tract Cancer is being studied. Conditions: Biliary Tract Cancer (BTC) • Eligibility: Inclusion Criteria: 1. Provide written informed consent prior to any study procedures and agree to adhere to all protocol requirements 2. Aged at least 18 years. 3. Has…. Goal: The object of this trial is to evaluate the efficacy of D07001-softgel capsules + capecitabine compared with placebo + capecitabine by overall survival (OS). Eligible patients with advanced biliary tract cancer (BTC) will be randomized (1:1:1) to receive either 60 mg D07001-softgel, 100 mg D07001-softgel, or placebo, combine with capecitabine. Phase/Status/Sponsor: Unknown phase; NOT_YET_RECRUITING; InnoPharmax Inc..

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Liver Cancer Prognosis Investigation Study is being studied. Conditions: Liver Neoplasms • Eligibility: Inclusion Criteria: * Age 18-80 years, * Diagnosed with primary liver cancer (ICD-10: C22) (Referring to the diagnostic criteria in the "Primary Liver Cancer Diagnosis and Treatment Guidelines…. Goal: This prospective cohort study is designed to explore the role of environmental, clinical, and genetic risk factors in the progression and prognosis of primary liver cancer (PLC). We will recruit 5000 patients with newly diagnosed, previously untreated PLC. Phase/Status/Sponsor: Unknown phase; NOT_YET_RECRUITING; Sun Yat-sen University.

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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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The trial tests an off-the-shelf, multi-peptide liver cancer vaccine (IMA970A) given with Montanide and the PD-L1 blocker Durvalumab. It is a single-arm, open-label Phase I study in adults with very early to intermediate stage hepatocellular carcinoma who have completed standard treatments and have no active disease. The study aims to assess safety, tolerability, and immune response to this combination and to see if it can reduce recurrence or progression. Eligibility includes adults over 18 with specific HLA types (HLA-A*02 or HLA-A*24), adequate organ function, and good performance status; key exclusions include recent systemic cancer treatment, liver transplantation, active autoimmune disease, prior anti-PD-1/PD-L1/CTLA-4 therapy with certain toxicities, and other high-risk conditions.

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- The study aims to find out how common spontaneous rupture of hepatocellular carcinoma (HCC) is among HCC patients at Assiut University Hospitals over the past five years, and to identify risk factors and predictors of rupture, as well as the one-year survival after rupture. - It includes adults 18 years and older who have HCC with rupture confirmed by imaging or surgery and who were admitted to the hospital during the study period. - Exclusions include traumatic liver rupture, non-HCC liver cancers, and cases with incomplete medical records or missing imaging data. - The study is not recruiting yet.

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In-depth Characterization of Circulating and Infiltrating Immune Subsets and Tumor Cells in Cancer Patients is being studied. Conditions: Head and Neck Cancer, Urologic Cancer, Lung Cancer +2 • Eligibility: Inclusion Criteria: * 18 years of age or older * Histologic, cytologic or imaging confirmation of a malignancy in accordance with targeted indications * Written informed consent signed…. Goal: The aim of this study is to describe the tumor microenvironment of solid tumors and to understand the changes induced by anti-cancer treatments, particularly those developed by Innate Pharma. Innate Pharma is a biotechnology company which discovers and develops therapeutic antibodies that exploit the innate immune system to improve cancer treatment. Phase/Status/Sponsor: Unknown phase; NOT_YET_RECRUITING; Assistance Publique Hopitaux De Marseille.

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Safety of Biliary Intraductal Radiofrequency Ablation in Patients With Unresectable Extrahepatic Biliary Tract Cancer is being studied. Conditions: Bile Duct Cancer • Eligibility: Inclusion criteria 1. Male or female ≥18 years old. 2. Histologically or cytologically confirmed diagnosis of previously untreated and unresectable\*, locally advanced and/or metastatic extrahepatic biliary tract cholangiocarcinoma…. Goal: The goal of this clinical trial is to provide evidence for the general tolerability of radiofrequency ablation (bRFA) in patients with unresectable bile duct cancer undergoing systemic palliative treatment consisting of chemotherapy (gemcitabine and cisplatin) plus durvalumab (immune-checkpoint-inhibitor, ICI). The main question it aims to answer is whether it is safe to combine chemotherapy (gemcitabine and cisplatin) and immunotherapy (durvalumab) - CICI therapy. Phase/Status/Sponsor: Unknown phase; NOT_YET_RECRUITING; Insel Gruppe AG, University Hospital Bern.

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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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- This prospective cohort study tests two post-conversion strategies for people with initially unresectable hepatocellular carcinoma who become eligible for surgery after receiving conversion therapy with TACE or HAIC plus anti-angiogenic agents and immune checkpoint inhibitors. - After achieving radiologic complete response or becoming resectable, participants will either have surgical liver resection or continue systemic therapy, and the study aims to compare outcomes between these two approaches. - Eligible participants are adults aged 18–75 with initially unresectable HCC, good liver function (Child-Pugh A/B) and ECOG 0–1, who have not had prior systemic therapy and have completed the conversion regimen. - Key exclusions include pregnancy, another active malignancy, Child-Pugh C liver function, incomplete radiologic data, and severe organ dysfunction.

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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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Summary not available yet.

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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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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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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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Summary not available yet.

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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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- This is a small, single‑center pilot study testing a treatment plan for adults with locally advanced hepatocellular carcinoma that cannot be removed by surgery. The regimen combines durvalumab with bevacizumab and hepatic arterial infusion chemotherapy (HAIC) followed by stereotactic body radiotherapy (SBRT). - The goal is to see if this approach can shrink tumors enough to convert them to resectable disease (conversion therapy) and to assess safety and signs of efficacy. - About 30 adults with intermediate or advanced HCC (ECOG 0–1, Child-Pugh A) who meet other criteria will be enrolled. - Key exclusions include major liver vessel invasion, prior liver radiotherapy, active autoimmune disease, HIV infection, pregnancy, and other active cancers or therapies.

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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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Dachengqi Decoction for Enhancing Early Gastrointestinal Recovery After Whipple Surgery is being studied. Conditions: Whipple Operation • Eligibility: Inclusion Criteria: * Patients aged 18-75 years, regardless of gender (n=45); * Meeting American Society of Anesthesiologists (ASA) physical status classification I-II criteria, scheduled to undergo pancreaticoduodenectomy or…. Goal: To investigate the clinical efficacy of the traditional Chinese medicine formula Dachengqi Decoction in promoting early gastrointestinal function recovery after Whipple surgery, and to evaluate its impact on postoperative nutritional status, hospitalization duration, and complication rates, thereby providing evidence for optimizing postoperative rehabilitation strategies in pancreaticoduodenectomy patients. Phase/Status/Sponsor: Unknown phase; ACTIVE_NOT_RECRUITING; China-Japan Friendship Hospital.

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Extracellular RNA Markers of Liver Disease and Cancer is being studied. Conditions: Hepatocellular Carcinoma, Biliary Tract Cancer, Cirrhosis +1 • Eligibility: Inclusion Criteria: * Lab results from within the previous 90 days. * Diagnosis of HCC or biliary tract cancer * Diagnosis of cirrhosis based on histology, imaging, or…. Goal: The study will examine and evaluate the use of extracellular RNA in blood as markers for the diagnosis of liver disease or cancer, and as markers for prediction of response to treatment or recurrence of cancer after surgery Phase/Status/Sponsor: Unknown phase; ACTIVE_NOT_RECRUITING; Mayo Clinic.

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Adjuvant Chemotherapy With Gemcitabine and Cisplatin Compared to Standard of Care After Curative Intent Resection of Biliary Tract Cancer is being studied. Conditions: Cholangiocarcinoma, Gall Bladder Carcinoma • Eligibility: All enrolled patients will postoperatively be assessed for eligibility for the treatment phase. Additionally patients not previously enrolled into the trial for whatever reason (e.g. incidental finding during…. Goal: This is a multicenter, prospective, randomized, controlled phase III trial designed to assess the clinical performance of gemcitabine with cisplatin and observation vs. standard of care (observation alone in stage 1 and capecitabine and observation in stage 2) in patients after curative intent resection of BTC. Phase/Status/Sponsor: Unknown phase; ACTIVE_NOT_RECRUITING; Universitätsklinikum Hamburg-Eppendorf.

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Efficacy of Tislelizumab and Spartalizumab Across Multiple Cancer-types in Patients with PD1-high MRNA Expressing Tumors is being studied. Conditions: MSI-H Colorectal Cancer, Melanoma, Anal Carcinoma +28 • Eligibility: Inclusion Criteria: 1. Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of PD1 mRNA high-expression…. Goal: This is an open-label, parallel group, non-randomized, multicenter phase II study to evaluate the efficacy of spartalizumab (cohorts 1 and 2) and tislelizumab (cohort 3) in monotherapy in patients with PD1-high-expressing tumors. Phase/Status/Sponsor: Unknown phase; ACTIVE_NOT_RECRUITING; SOLTI Breast Cancer Research Group.

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A Study to Evaluate INCB099280 in Participants With Select Solid Tumors Who Are Immune Checkpoint Inhibitor Naive is being studied. Conditions: Advanced Solid Tumor • Eligibility: Inclusion Criteria: * Immunotherapy naive and without access to approved and/or available immune checkpoint inhibitor (ICI) therapy. * Measurable disease per RECIST v1.1. * One of the following…. Goal: This study is being conducted to determine the safety, tolerability, and preliminary efficacy of INCB099280 in participants with advanced solid tumors. Phase/Status/Sponsor: Unknown phase; ACTIVE_NOT_RECRUITING; Incyte Corporation.

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Summary not available yet.

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The study tests whether detecting cell-surface plectin on ERCP-obtained biliary samples can improve diagnosis of cholangiocarcinoma. It is for patients who have a biliary stricture or mass seen on imaging and are already undergoing ERCP as part of their usual care. During ERCP, participants will have an extra biopsy or brush sample analyzed to see if cell-surface plectin can be detected and whether this is more sensitive than standard cytology alone. The trial is not recruiting yet, and key exclusions are being under 18 years old or unable to consent.

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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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Role of Long Noncoding RNA LINC01134 in Metastasis of Hepatitis C Virus-related Hepatocellular Carcinoma is being studied. Conditions: Hepatocellular Carcinoma (HCC) • Eligibility: Inclusion Criteria: * The diagnosis of HCV infection will be based on positive HCV antibodies by enzyme-linked immunosorbent assay (ELISA) \& HCV RNA by polymerase chain reaction (PCR)…. Goal: LINC01134, a novel lncRNA, has received increasing attention in cancer research, particularly in hepatocellular carcinoma (HCC). It had been shown that LINC01134 promotes HCC progression by facilitating tumor proliferation, migration, epithelial-mesenchymal transition, oxaliplatin resistance, and radio resistance (Wang et al,2021). Phase/Status/Sponsor: Unknown phase; NOT_YET_RECRUITING; Sohag University.

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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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- This is an observational cohort study of chronic hepatitis B infection in Zambian adults and does not involve a new treatment. - It will enroll 500 adults with chronic HBV at University Teaching Hospital and follow them for up to five years. - The study aims to describe patients’ clinical features and track viral, serologic, and liver outcomes over time, including cirrhosis and liver cancer, as well as the real-world effectiveness of treatments used. - Eligibility requires 18 years or older and a positive HBsAg test; key exclusions are inability or unwillingness to consent and being HIV-positive.

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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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- The trial tests hepatologists’ knowledge, attitudes, and use of non-invasive HCC prediction models in patients with chronic hepatitis C who achieved SVR after DAA therapy. - It will use a structured online questionnaire sent to hepatologists worldwide who have at least one year of experience managing HCV. - The study aims to learn what proportion of hepatologists currently incorporate these models into practice, and to assess their knowledge, perceived reliability, and barriers to adoption. - It also seeks to identify factors associated with poor adoption of these predictive models. - Eligibility requires hepatologists with at least one year of experience; non-hepatologists, general practitioners, or respondents who submit incomplete surveys are excluded. Status: NOT_YET_RECRUITING.

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- This study is testing alectinib (an ALK inhibitor) plus nivolumab (an anti-PD-1 drug) in people with recurrent or refractory hepatocellular carcinoma (HCC) that has failed previous tyrosine kinase inhibitors. - It uses serum RNase1 and tumor PD-L1 expression as biomarkers to guide treatment and to see who might respond. - The goal is to learn whether RNase1 and PD-L1 can predict benefit from this combo therapy, in a small pilot of eight evaluable patients. - Eligibility includes adults 20 or older with ALK-wild-type HCC, measurable disease, and adequate organ function, while key exclusions include prior anti-PD-1/PD-L1 or ALK inhibitor therapy, active CNS metastases, and other serious illnesses.

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TAS102 in Combination With NAL-IRI in Advanced GI Cancers is being studied. Conditions: Colorectal Adenocarcinoma, Gastric Adenocarcinoma, Metastatic Pancreatic Adenocarcinoma +11 • Eligibility: Inclusion Criteria: * Subjects must have histologic or cytological confirmation of a malignancy that is advanced (metastatic and/or unresectable) with measurable disease per Response Evaluation Criteria in Solid…. Goal: This phase I/II trial studies the best dose and how well trifluridine/tipiracil hydrochloride combination agent TAS-102 (TAS-102) and nanoliposomal irinotecan work in treating patients with gastrointestinal cancers that have spread to other places in the body (metastatic) or cannot be removed by surgery. Drugs used in the chemotherapy, such as trifluridine/tipiracil hydrochloride combination agent TAS-102 and nanoliposomal irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Phase/Status/Sponsor: Unknown phase; ACTIVE_NOT_RECRUITING; Emory University.

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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 open-label Phase I/II trial tests AST-3424 as a single agent in adults with advanced solid tumors to assess safety, tolerability, pharmacokinetics, and early signs of activity. - In Phase II, the study will focus on people with advanced hepatocellular carcinoma who have strong AKR1C3 expression in their tumors, to see if AKR1C3 status relates to response. - The study will start with dose escalation to find the maximum tolerated dose, then treat at that dose in the expansion phase. - The trial is currently not recruiting; eligibility includes adults 18–70 for Phase I with various metastatic/unresectable tumors, and Phase II requires ECOG 0–1, advanced HCC with high AKR1C3 expression, and certain health criteria, with exclusions such as pregnancy, breastfeeding, untreated active CNS metastases, and HIV or active infections.

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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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Summary not available yet.

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Summary not available yet.

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HCC Innervation Assessment is being studied. Conditions: Hepatocarcinoma • Eligibility: Inclusion Criteria: * Patients with hepatocarcinoma who undergo surgical resection or liver transplant * Patients with and without treatment Exclusion Criteria: * \- Pregnant or lactating women *…. Goal: Primary liver cancer casualties are ranked 3rd worldwide and are still on the rise despite the recent advent of adequate hepatitis B and C therapies. Genetic diseases of the liver and hepatic comorbidities, such as alcoholic liver disease and metabolic syndrome with metabolic-associated steatohepatitis, are long-term cooperators or independent factors fostering the onset of hepatocellular carcinoma (HCC) and enhancing disease heterogeneity. Phase/Status/Sponsor: Unknown phase; ACTIVE_NOT_RECRUITING; Hospices Civils de Lyon.

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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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- 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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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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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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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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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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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 trial tests immune therapies durvalumab and tremelimumab, with or without the chemotherapy capecitabine, as adjuvant treatment after curative surgery for biliary tract cancer. - It is for adults whose biliary tract cancer was completely resected with no metastasis, within 16 weeks of surgery, and who have good performance status. - The main goal is to see whether the treatment improves recurrence-free survival at 12 months, with secondary aims including overall survival, safety, quality of life, and biomarker analyses. - In a pilot phase, 40 patients are randomized 1:1 to receive durvalumab+tremelimumab with or without capecitabine to identify the more promising approach for potential testing against the current standard capecitabine; key exclusions include metastatic disease, active infection, prior immunotherapy, and autoimmune disorders.

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Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966)-China Extension Study is being studied. Conditions: Biliary Tract Carcinoma • Eligibility: Inclusion Criteria * Has histologically confirmed diagnosis of advanced (metastatic) and/or unresectable (locally advanced) biliary tract cancer (intra-or extrahepatic cholangiocarcinoma or gallbladder cancer) * Has measurable disease based…. Goal: In this China Extension study, pembrolizumab plus gemcitabine/cisplatin will be compared with placebo plus gemcitabine/cisplatin as first-line therapy in Chinese adults with advanced and/or unresectable biliary tract carcinoma. The primary hypothesis is pembrolizumab plus gemcitabine/cisplatin is superior to placebo plus gemcitabine/cisplatin with respect to overall survival (OS). Phase/Status/Sponsor: Unknown phase; COMPLETED; Merck Sharp & Dohme LLC.

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- This study tests RXC004 alone and in combination with pembrolizumab in adults whose advanced solid tumors progressed after standard therapy. - It has three parts: Module 1 treats RNF43 loss-of-function pancreatic cancer, Module 2 treats biliary tract cancer, and Module 3 tests RXC004 with pembrolizumab in BTC. - The goal is to learn early signs of benefit, using progression-free survival at 6 months for Modules 1 and 2 and objective response rate for Module 3, along with safety data. - Eligible participants must have measurable disease and adequate organ function; key exclusions include prior RXC004 exposure, brain metastases, active infections, pregnancy, and in Module 3, prior PD-1/PD-L1 therapy or pembrolizumab-related contraindications.

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A Phase 1/2 Safety Study of Intratumorally Dosed INT230-6 is being studied. Conditions: Breast Cancer, Head and Neck Cancer, Squamous Cell Carcinoma +8 • Eligibility: Inclusion Criteria: INT230-6 monotherapy Cohorts EC2 and EC3, combination with KEYTRUDA® cohort DEC2 and combination with Yervoy cohort FEC. Where criteria diverge the DEC2 and FEC specific criteria…. Goal: This study evaluated the intratumoral administration of escalating doses of a novel, experimental drug, INT230-6. The study was conducted in patients with several types of refractory cancers including those at the surface of the skin (breast, squamous cell, head and neck) and tumors within the body such (pancreatic, colon, liver, lung, etc.). Phase/Status/Sponsor: Unknown phase; COMPLETED; Intensity Therapeutics, Inc..

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The Registry of Oncology Outcomes Associated with Testing and Treatment is being studied. Conditions: Adenocarcinoma, Adenocystic Carcinoma, Anal Cancer +73 • Eligibility: Inclusion Criteria: * Patient or representative provides written informed consent * Patient is diagnosed with advanced malignancy * Patient is willing to be treated for this malignancy according…. Goal: This study is to collect and validate regulatory-grade real-world data (RWD) in oncology using the novel, Master Observational Trial construct. This data can be then used in real-world evidence (RWE) generation. Phase/Status/Sponsor: Unknown phase; COMPLETED; Taproot Health.

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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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The trial tests TT-00420 (Tinengotinib) as a tablet given alone and in combination for adults with advanced solid tumors. It has three arms: Arm A tests TT-00420 alone in various advanced cancers; Arm B combines TT-00420 with atezolizumab for advanced biliary tract cancer; Arm C combines TT-00420 with nab-paclitaxel for advanced triple-negative breast cancer. The study is a Phase Ib/II, multicenter, open-label trial that aims to find a safe and tolerable dose for the next phase and then evaluate preliminary efficacy in each arm. Eligibility includes adults 18 or older with measurable disease and adequate organ function; key exclusions include pregnancy, active HIV/HBV/HCV infection, significant heart problems or QT prolongation, active brain metastases, and recent systemic anticancer therapy or conflicting medications. Status: COMPLETED. Sponsor: TransThera Sciences (Nanjing), Inc.

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Real-Time Monitoring of Chemotherapy Side-Effects in Patients With Gastrointestinal Cancers, RT-CAMSS Study is being studied. Conditions: Clinical Stage 0 Esophageal Adenocarcinoma AJCC v8, Clinical Stage 0 Esophageal Squamous Cell Carcinoma AJCC v8, Clinical Stage 0 Gastric Cancer AJCC v8 +83 • Eligibility: Inclusion Criteria: * Patients diagnosed with gastric, esophageal, pancreatic or colorectal cancer * Scheduled to start intravenous (IV) chemotherapy or has started IV chemotherapy * Able to read…. Goal: This trial tests new methods and materials for the real-time chemotherapy-associated side effects monitoring support system (RT-CAMSS) in patients with gastrointestinal cancers undergoing chemotherapy. RT-CAMSS is a monitoring support system that provides patients with evidence-based information and side-effect management and coping skills, emotional support and validation, and proactive care via text messages and questionnaires as they undergo chemotherapy. Phase/Status/Sponsor: Unknown phase; COMPLETED; Thomas Jefferson University.

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Preventing Viral Pandemic Associated Risk of Cancer Death Using Less Invasive Diagnostic Tests- Liquid Biopsies is being studied. Conditions: Neoplasm, Colorectal, Neoplasm of Lung, Neoplasm, Bladder +3 • Eligibility: Inclusion Criteria: * Participants aged ≥18 years old * Patients with suspected malignancies of early stage colorectal cancer (FIT intermediate and high risk), early and late stage pancreatic…. Goal: The purpose of this study is to investigate the feasibility of using ctDNA to support cancer diagnosis and risk stratification where invasive aerosol generating testing (and/or tissue biopsy) is challenging due to infection risk, technical impracticalities and resource limitations, such as during the COVID-19 pandemic and the subsequent recovery period. Phase/Status/Sponsor: Unknown phase; COMPLETED; Royal Marsden NHS Foundation Trust.

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