Ongoing Clinical Trials for Bile Duct Cancer
There are currently 6 ongoing clinical trials investigating new treatments for bile duct cancer. These studies are testing various medications including targeted therapies, immunotherapies, and combination treatments across multiple European countries. The trials include patients with advanced or metastatic disease and aim to evaluate both the safety and effectiveness of novel therapeutic approaches.
Clinical trial locations
- Belgium
- Denmark
- France
- Study of DS-3939a for Patients with Advanced or Metastatic Solid Tumors
- Study on the Effectiveness and Safety of BAY 2927088 for Patients with Advanced Solid Tumors with HER2 Mutations
- Study on the Safety and Effectiveness of Patritumab Deruxtecan for Patients with Colorectal, Biliary Tract, and Liver Cancer
- Study on Capecitabine and Durvalumab for Patients with Removed Biliary Tract Cancer
- Study on Pembrolizumab, Lenvatinib, and Belzutifan for Patients with Liver, Colon, Pancreatic, Bile Duct, Gallbladder, Endometrial, or Esophageal Cancer
- Italy
- Study on the Effectiveness and Safety of BAY 2927088 for Patients with Advanced Solid Tumors with HER2 Mutations
- Study on the Effects of Volrustomig and Drug Combination for Patients with Advanced Hepatobiliary Cancer
- Study on the Safety and Effectiveness of Patritumab Deruxtecan for Patients with Colorectal, Biliary Tract, and Liver Cancer
- Netherlands
- Spain
- Study of DS-3939a for Patients with Advanced or Metastatic Solid Tumors
- Study on the Effectiveness and Safety of BAY 2927088 for Patients with Advanced Solid Tumors with HER2 Mutations
- Study on the Effects of Volrustomig and Drug Combination for Patients with Advanced Hepatobiliary Cancer
- Study on the Safety and Effectiveness of Patritumab Deruxtecan for Patients with Colorectal, Biliary Tract, and Liver Cancer
- Study on Pembrolizumab, Lenvatinib, and Belzutifan for Patients with Liver, Colon, Pancreatic, Bile Duct, Gallbladder, Endometrial, or Esophageal Cancer
Study of DS-3939a for Patients with Advanced or Metastatic Solid Tumors
This trial is testing DS-3939a, a new medication given through an intravenous infusion, for patients with advanced solid tumors including bile duct cancer. The study aims to evaluate the safety and tolerability of this treatment and how well it works in treating cancers that have spread beyond their original location.
Inclusion criteria: Participants must be adults who have signed an informed consent form and have adequate organ function with a heart ejection fraction of at least 50%. They should have measurable disease according to RECIST V1.1 criteria and an ECOG performance status score of 0 or 1, meaning they are fully active or have some symptoms but can carry out light work. For Part 1 of the study, patients need a confirmed diagnosis of locally advanced, metastatic, or unresectable cancer in the bile duct or other specified organs. For Part 2, patients must show disease progression on scans during or after their most recent treatment and provide a tumor sample.
Exclusion criteria: Patients with metastatic or advanced solid tumors who are outside the specified age range, belong to vulnerable populations, or do not meet safety and tolerability requirements for DS-3939a cannot participate.
Focus: The trial focuses on assessing how the body handles DS-3939a and measuring its effectiveness at shrinking tumors. The study is divided into two parts: the first part evaluates safety and tolerability, while the second part measures the treatment’s effectiveness at a recommended dose using objective response rate as a key measure.
Investigational drug: DS-3939a is designed to help treat advanced solid tumors by targeting specific pathways that cancer cells use to grow and spread. It falls under the category of experimental cancer therapies currently under investigation.
Study on the Effectiveness and Safety of BAY 2927088 for Patients with Advanced Solid Tumors with HER2 Mutations
This study is investigating BAY 2927088, an oral medication that works as a reversible tyrosine kinase inhibitor, for patients with advanced solid tumors that have a specific genetic change known as a HER2 mutation. The trial includes patients with bile duct cancer and aims to determine how well the treatment works and its safety profile.
Inclusion criteria: Participants must be at least 18 years old with a confirmed diagnosis of a solid tumor that is metastatic or cannot be surgically removed. They must have an activating HER2 mutation and at least one measurable tumor area according to RECIST 1.1 criteria. Patients should have already tried standard treatments for their cancer type and stage, or have no other satisfactory treatment options available.
Exclusion criteria: Patients without a HER2 mutation, those outside the specified age range, pregnant or breastfeeding women, and those unable to follow study procedures cannot participate. Patients with certain medical conditions, allergies to the study medication, or who recently participated in another trial may also be excluded.
Focus: The trial monitors tumor response through regular imaging tests to measure objective response rate, duration of response, and time to response. Safety assessments track any adverse events, and quality of life is evaluated using standardized questionnaires throughout the treatment period, which can last up to 36 months.
Investigational drug: BAY 2927088 is taken as a coated tablet and works by inhibiting specific proteins known as tyrosine kinases that help cancer cells grow. It specifically targets tumors with HER2 mutations that can promote cancer progression.
Study on the Effects of Volrustomig and Drug Combination for Patients with Advanced Hepatobiliary Cancer
This trial explores treatments for advanced hepatobiliary cancer, which includes cancers affecting the liver, gallbladder, and bile ducts. The study tests new immunomodulators, medications designed to help the immune system fight cancer, both alone and in combination with other cancer-fighting drugs.
Inclusion criteria: Participants must be at least 18 years old with a confirmed diagnosis of locally advanced or metastatic solid tumor as specified by the study. They need adequate organ and bone marrow function, at least one measurable tumor not previously treated with radiation, and a life expectancy of at least 12 weeks. Patients must also be willing to provide a tumor sample.
Exclusion criteria: Patients with cancer types other than advanced hepatobiliary cancer, those who received certain treatments within a specific timeframe before the study, pregnant or breastfeeding women, and those with severe or uncontrolled medical conditions cannot participate. Patients with known allergies to study drugs, those unable to comply with study procedures, or with certain mental health or substance abuse histories may also be excluded.
Focus: The study evaluates how well immunomodulators work in shrinking tumors and stopping cancer growth, both when used alone and in combination with other medications such as gemcitabine, cisplatin, and bevacizumab. Researchers track tumor response, duration of response, and overall survival while monitoring safety.
Investigational drugs: Novel immunomodulators are designed to boost the immune system’s ability to detect and destroy cancer cells. They are tested alongside anticancer agents that kill cancer cells or stop them from growing to determine if the combination is more effective than using immunomodulators alone.
Study on the Safety and Effectiveness of Patritumab Deruxtecan for Patients with Colorectal, Biliary Tract, and Liver Cancer
This clinical trial tests patritumab deruxtecan, a special type of drug known as a monoclonal antibody, for patients with biliary tract cancer and other gastrointestinal cancers. The medication is designed to target specific proteins in cancer cells and is given through intravenous infusion.
Inclusion criteria: Participants must have colorectal carcinoma, biliary tract carcinoma, or hepatocellular carcinoma with a performance status of 0 to 1, meaning they are fully active or restricted in strenuous activity but still mobile. Patients with hepatitis B or C history can join if they meet specific viral suppression criteria. For second-line biliary tract cancer, patients must have received one previous gemcitabine-based treatment or two previous treatments including gemcitabine.
Exclusion criteria: Patients with medical conditions other than the specified cancer types, those outside the specified age range, or those who are part of vulnerable populations cannot participate.
Focus: The study monitors safety and tolerability, checking for dose-limiting toxicities and adverse events. It measures objective response rate to assess tumor size reduction and evaluates duration of response, progression-free survival, and overall survival. Blood samples are collected to determine medication concentrations in the plasma.
Investigational drug: Patritumab deruxtecan is an antibody-drug conjugate that targets the HER3 receptor on cancer cells, delivering a cytotoxic agent directly to them to inhibit their growth and survival. It combines a monoclonal antibody with a chemotherapy drug to enhance its cancer-fighting capabilities.
Study on Capecitabine and Durvalumab for Patients with Removed Biliary Tract Cancer
This trial investigates treatments for patients who have had their bile duct cancer surgically removed. It compares a combination of capecitabine and durvalumab against capecitabine alone to see which approach is better at preventing cancer from returning.
Inclusion criteria: Participants must be at least 18 years old, weigh more than 30 kg, and have a life expectancy of at least 3 months. They need to provide written informed consent, have adequate organ function, and be part of a social security scheme. Women of childbearing potential must show proof of being post-menopausal or have a negative pregnancy test. Patients must have completely resected bile duct cancer with no signs of spread on recent CT scans, surgery performed between 4 and 12 weeks before starting treatment, and no DPD deficiency. They should have an ECOG performance status of 0-1 and available tumor tissue samples.
Exclusion criteria: Patients who have not had surgery to remove their cancer, those with another type of cancer, pregnant or breastfeeding women, and those with serious infections or illnesses cannot participate. Patients with organ transplants, taking certain interfering medications, those with severe allergic reactions to similar drugs, weakened immune systems, recent participation in other trials, or mental health conditions affecting study compliance are also excluded.
Focus: The study aims to evaluate whether the combination of capecitabine and durvalumab can improve the time patients remain cancer-free compared to capecitabine alone. It assesses treatment safety, quality of life, and cancer recurrence through regular monitoring and follow-up visits.
Investigational drugs: Capecitabine is a chemotherapy medication that interferes with cancer cell growth, given as an adjuvant therapy after surgery to prevent recurrence. Durvalumab is an immunotherapy drug that blocks a protein cancer cells use to hide from the immune system, helping the immune system recognize and attack cancer cells more effectively.
Study on Pembrolizumab, Lenvatinib, and Belzutifan for Patients with Liver, Colon, Pancreatic, Bile Duct, Gallbladder, Endometrial, or Esophageal Cancer
This trial studies the combination of three medications for patients with various cancers including bile duct and gallbladder cancer. Pembrolizumab is given as an intravenous infusion, while lenvatinib and belzutifan are taken orally as capsules and tablets respectively.
Inclusion criteria: Participants must be at least 18 years old with a diagnosis of advanced cancer that cannot be removed surgically or has spread to other parts of the body. They need measurable tumors according to specific guidelines and must provide tumor tissue samples. For bile duct or gallbladder cancer, patients must have received at least one previous treatment that included specific drugs. The cancer must be unresectable or metastatic.
Exclusion criteria: Patients with the specified cancer types including bile duct or gallbladder cancer cannot participate, though the specific additional exclusion criteria are not fully detailed in the available information.
Focus: The study evaluates the safety and effectiveness of using pembrolizumab, lenvatinib, and belzutifan together. Participants receive the combination treatment and undergo regular monitoring through check-ups, blood tests, and imaging studies to track cancer response and identify any side effects. The trial assesses tumor response using specific criteria evaluated by independent reviewers.
Investigational drugs: Pembrolizumab is a monoclonal antibody that blocks a protein on cancer cells to help the immune system attack them. Lenvatinib targets proteins involved in cancer cell growth to slow tumor development. Belzutifan inhibits a protein that helps cancer cells survive in low-oxygen environments, making it harder for them to grow and spread.
Summary
The six ongoing clinical trials for bile duct cancer represent a diverse range of therapeutic approaches being investigated across Europe. France and Spain lead in trial availability, each hosting five studies, followed by Italy and Belgium with three and two trials respectively. Denmark and the Netherlands each host one trial.
The trials reflect current trends in cancer treatment research, with a strong focus on immunotherapy approaches. Several studies investigate immunomodulators and immune checkpoint inhibitors, either alone or in combination with traditional chemotherapy or targeted therapies. Notably, multiple trials include bile duct cancer as part of broader studies examining advanced solid tumors or gastrointestinal cancers, reflecting the complexity of these diseases and the potential for treatments that work across multiple cancer types.
Treatment approaches vary from single-agent studies to complex combination regimens involving two or three medications. Some trials focus on patients with specific genetic mutations, such as HER2 alterations, representing a move toward personalized medicine. One trial specifically addresses the post-surgical setting, investigating treatments to prevent cancer recurrence after complete tumor removal.
Most studies are in early to mid-stage phases, focusing on establishing safety profiles and preliminary effectiveness data. The trials are expected to conclude between 2027 and 2028, with results potentially influencing future treatment options for patients with bile duct cancer.
