Ongoing Clinical Trials for Gallbladder Cancer
There are currently 7 clinical trials actively recruiting patients with gallbladder cancer across Europe. These studies are investigating various treatment approaches including targeted therapies, immunotherapies, and chemotherapy combinations, conducted in multiple countries including Germany, Spain, Italy, France, Netherlands, Belgium, Austria, and Denmark.
Clinical trial locations
- Austria
- Belgium
- Denmark
- France
- Germany
- Study of Durvalumab, Tremelimumab, and Capecitabine for Patients with Biliary Tract Cancer in an Adjuvant Setting
- Study on Gemcitabine and Cisplatin for Patients After Surgery for Bile Duct or Gallbladder Cancer
- Study on the Effectiveness and Safety of Gemcitabine, Cisplatin, Trastuzumab, and Pembrolizumab for Untreated HER2-Positive Biliary Tract Cancer Patients
- Italy
- Study on Gemcitabine and Cisplatin for Patients After Surgery for Bile Duct or Gallbladder Cancer
- Study on the Effects of Volrustomig and Drug Combination for Patients with Advanced Hepatobiliary Cancer
- Study on the Effectiveness and Safety of BAY 2927088 for Patients with Advanced Solid Tumors with HER2 Mutations
- Netherlands
- Spain
- Study of CYC140 oral medication for patients with advanced solid tumors and lymphoma
- Study on Pembrolizumab, Lenvatinib, and Belzutifan for Patients with Liver, Colon, Pancreatic, Bile Duct, Gallbladder, Endometrial, or Esophageal Cancer
- Study on the Effects of Volrustomig and Drug Combination for Patients with Advanced Hepatobiliary Cancer
- Study on the Effectiveness and Safety of BAY 2927088 for Patients with Advanced Solid Tumors with HER2 Mutations
Study on the Effectiveness and Safety of BAY 2927088 for Patients with Advanced Solid Tumors with HER2 Mutations
This trial is investigating BAY 2927088, an oral medication taken as a tablet, for patients with advanced solid tumors that have a specific genetic change called a HER2 mutation. The medication works as a reversible tyrosine kinase inhibitor, blocking certain proteins that help cancer cells grow.
Main inclusion criteria: Participants must be at least 18 years old and have an advanced solid tumor, including biliary tract cancer, that cannot be removed by surgery or has spread to other parts of the body. The tumor must have a HER2-activating mutation confirmed by testing. Patients should have already tried standard treatments for their cancer type and stage, or have no other satisfactory treatment options available. At least one tumor area must be measurable according to RECIST 1.1 criteria.
Main exclusion criteria: Patients without a HER2 mutation, those who are pregnant or breastfeeding, and patients with certain medical conditions that could interfere with the study cannot participate. Recent participation in another clinical trial or specific allergies to the study medication may also exclude patients.
Study focus: The trial aims to evaluate how well BAY 2927088 works in reducing tumor size or stopping tumor growth, as well as its safety profile. Researchers will monitor the objective response rate, duration of response, progression-free survival, and overall survival. The study also assesses quality of life and tracks any treatment-related side effects throughout the 36-month treatment period.
Treatment location: Denmark, Italy, France, Spain
Study on the Effectiveness and Safety of Gemcitabine, Cisplatin, Trastuzumab, and Pembrolizumab for Untreated HER2-Positive Biliary Tract Cancer Patients
This German trial examines a combination treatment for HER2-positive biliary tract cancer, including cholangiocarcinoma and gallbladder carcinoma. The study evaluates the effectiveness and safety of combining four medications: Gemcitabine, Cisplatin (together known as GemCis), Trastuzumab, and Pembrolizumab, all administered intravenously.
Main inclusion criteria: Patients must be at least 18 years old with a confirmed diagnosis of cholangiocarcinoma or gallbladder cancer that is HER2-positive. The cancer must not be eligible for surgery. Patients should have an ECOG performance status of 0 to 1, meaning they can carry out normal activities with little or no restriction. They must have measurable disease according to RECIST v1.1 guidelines and adequate organ function. Both male and female participants must agree to use contraception during treatment and for at least 7 months afterward.
Main exclusion criteria: Patients with other cancer types, those outside the specified age range, patients unable to provide informed consent, and those considered part of vulnerable populations requiring special protection cannot participate.
Study focus: The primary goal is to assess the objective response rate at six months, meaning how many participants experience significant tumor reduction. The study will also measure progression-free survival, overall survival, and treatment safety by recording side effects and adverse events throughout the 24-month trial period.
Investigational drugs: GemCis is a standard chemotherapy combination that stops cancer cell growth. Trastuzumab is a targeted therapy that attaches to the HER2 protein on cancer cells, helping to stop their growth and allowing the immune system to destroy them. Pembrolizumab is an immunotherapy that helps the immune system recognize and attack cancer cells by blocking a specific protein.
Treatment location: Germany
Study on the Effects of Volrustomig and Drug Combination for Patients with Advanced Hepatobiliary Cancer
This trial investigates treatments for advanced hepatobiliary cancer, which affects the liver, gallbladder, and bile ducts. The study explores new immunomodulators, medications designed to help the immune system fight cancer, both alone and in combination with other cancer-fighting drugs including Gemcitabine, Cisplatin, Volrustomig (MEDI5752), Bevacizumab, Lenvatinib, Rilvegostomig (AZD2936), and Infliximab.
Main inclusion criteria: Participants must be at least 18 years old with a confirmed diagnosis of locally advanced or metastatic hepatobiliary cancer based on tissue examination. They must have adequate organ and bone marrow function, at least one measurable tumor that hasn’t been treated with radiation, and a life expectancy of at least 12 weeks. Patients must be willing to provide a tumor sample for the study.
Main exclusion criteria: Patients with other types of cancer, those who received certain cancer treatments within a specific timeframe before the study, individuals with severe uncontrolled medical conditions, pregnant or breastfeeding women, and patients unable to comply with study procedures may be excluded. Known allergies to study drugs and history of substance abuse that could interfere with the study are also exclusion factors.
Study focus: The trial evaluates how well these treatments work in shrinking tumors and preventing cancer growth, while assessing their safety profile. Researchers will collect information on treatment response, response duration, overall survival, blood levels of immunomodulators, and immune reactions to these new therapies throughout the 12-month study period.
Treatment administration: Medications are given through intravenous infusions directly into the bloodstream or taken orally as capsules or tablets.
Treatment location: Italy, Spain
Study on Gemcitabine and Cisplatin for Patients After Surgery for Bile Duct or Gallbladder Cancer
This trial focuses on preventing cancer recurrence after surgery in patients with cholangiocarcinoma (bile duct cancer) or muscle invasive gallbladder carcinoma. The study compares the combination of gemcitabine and cisplatin with standard care, which may include observation alone or treatment with capecitabine.
Main inclusion criteria: Patients must have adenocarcinoma of the biliary tract or muscle invasive gallbladder carcinoma and be scheduled for surgery aimed at complete cancer removal. They must be at least 18 years old and provide written informed consent. Patients should not have received previous chemotherapy for biliary tract cancer or had other cancers in the last 3 years (with some exceptions). They must have adequate blood, liver, and kidney function, and those of childbearing potential must agree to use effective birth control. Women must not be pregnant or breastfeeding.
Main exclusion criteria: Patients who haven’t had curative surgery, those with signs of cancer spreading to other body parts (metastatic disease), individuals with serious heart problems or active uncontrolled infections, and patients taking other experimental drugs or cancer treatments within 30 days before study start cannot participate.
Study focus: The primary goal is to evaluate disease-free survival, meaning how long patients remain cancer-free after surgery. The study also assesses overall survival and quality of life throughout the treatment period, which is expected to conclude by the end of 2025.
Investigational drugs: Gemcitabine interferes with cancer cell growth by slowing or stopping their spread. Cisplatin kills cancer cells by damaging their DNA, preventing division and growth. In some cases, capecitabine, an oral chemotherapy drug converted to 5-fluorouracil in the body, is used as part of standard care to stop cancer cell growth.
Treatment location: Austria, Italy, Netherlands, Germany
Study of CYC140 oral medication for patients with advanced solid tumors and lymphoma
This Spanish trial evaluates CYC140, an oral PLK1 inhibitor taken in capsule form, for patients with advanced solid tumors and lymphoma. The medication works by blocking a specific protein involved in cancer cell growth.
Main inclusion criteria: Patients must be at least 18 years old with confirmed advanced cancer that has progressed despite standard treatment, cannot be tolerated, or has no standard treatment options available. They must have documented cancer worsening on imaging scans and at least one measurable tumor. An ECOG performance status of 0-2 is required, meaning patients should be able to perform daily activities or light activities with rest less than half the day. Women who can become pregnant must have a negative pregnancy test within 7 days before starting treatment. Both men and women of childbearing potential must use effective birth control during the study and for 6 months after. Patients must be able to swallow oral medications.
Main exclusion criteria: Prior treatment with CYC140, active or unstable brain metastases, ongoing significant side effects from previous treatments, severe heart conditions, uncontrolled high blood pressure, major surgery within 4 weeks, active uncontrolled infections, HIV or hepatitis B/C infection, pregnancy or breastfeeding, participation in another trial within 4 weeks, life expectancy less than 3 months, significant kidney or liver problems, and known allergic reactions to similar medications.
Study focus: The study is divided into two parts. The first evaluates different doses to find the most appropriate amount. The second assesses how well the medication works in treating cancer. Throughout the trial, researchers monitor tumor response, safety, and side effects. Treatment continues in 28-day cycles as long as it remains beneficial.
Treatment location: Spain
Study of Durvalumab, Tremelimumab, and Capecitabine for Patients with Biliary Tract Cancer in an Adjuvant Setting
This German trial investigates a combination of immunotherapy and chemotherapy for biliary tract cancer patients after surgery. The study evaluates durvalumab (MEDI4736) and tremelimumab, both immunotherapies, with or without capecitabine, a chemotherapy drug, to prevent cancer recurrence.
Main inclusion criteria: Patients must be at least 18 years old with confirmed biliary tract cancer that has been surgically removed without signs of spreading. Surgery should have occurred within the last 16 weeks. Participants must have a performance status of 1 or less, meaning they can carry out daily activities without significant help, and a life expectancy of at least 12 weeks. They must have adequate blood, liver, and kidney function, including sufficient white blood cells, platelets, and hemoglobin, with normal levels of bilirubin, liver enzymes, and creatinine. Those of reproductive age must agree to use effective birth control during the study and for a period afterward, with women requiring a negative pregnancy test before starting.
Main exclusion criteria: Patients with cancer types other than biliary tract cancer, those unable to follow study procedures or with conditions making participation unsafe, pregnant or breastfeeding women, recent participants in other clinical trials, individuals unable to provide informed consent, and those with certain medical conditions that could interfere with the study cannot participate.
Study focus: The primary goal is to assess the recurrence-free survival rate at 12 months. Secondary goals include overall survival, treatment safety, and quality of life assessments. The study will conclude by April 2025, with regular monitoring through physical exams, blood tests, and imaging studies throughout the treatment period.
Investigational drugs: Durvalumab is an immunotherapy that blocks a protein preventing the immune system from attacking cancer cells. Tremelimumab enhances the immune system’s cancer-fighting ability by targeting a protein that suppresses immune response. Capecitabine is a chemotherapy medication that interferes with cancer cell growth and division.
Treatment location: Germany
Study on Pembrolizumab, Lenvatinib, and Belzutifan for Patients with Liver, Colon, Pancreatic, Bile Duct, Gallbladder, Endometrial, or Esophageal Cancer
This trial studies a three-medication combination for several cancer types, including bile duct and gallbladder cancer. The treatment includes Pembrolizumab (MK-3475) given as an intravenous infusion, Lenvatinib (MK-7902) taken as oral capsules, and Belzutifan (MK-6482) taken as oral tablets.
Main inclusion criteria: Patients must have advanced cancer that cannot be removed by surgery or has spread to other body parts. They must have at least one measurable tumor and provide a tumor tissue sample. Specific requirements vary by cancer type: bile duct or gallbladder cancer patients must have had at least one previous treatment including specific drugs. Patients must be at least 18 years old, and both males and females can participate.
Main exclusion criteria: The specific exclusion criteria focus on patients with the listed cancer types only. Other cancer types cannot participate in this trial.
Study focus: The trial evaluates the safety and effectiveness of this three-drug combination. Researchers monitor tumor response using specific criteria evaluated by independent reviewers. Regular assessments include physical exams, blood tests, and imaging studies to track treatment response and side effects.
Investigational drugs: Pembrolizumab helps the immune system fight cancer by blocking a protein on cancer cells. Lenvatinib targets proteins involved in cancer cell growth and blood vessel formation, inhibiting tumor growth. Belzutifan works by inhibiting a protein that helps cancer cells survive in low-oxygen environments, making it harder for cancer to grow and spread.
Treatment location: Netherlands, France, Spain, Belgium
Summary
The current landscape of clinical trials for gallbladder cancer reflects a diverse approach to treatment, with 7 active studies across multiple European countries. Germany stands out as a significant research hub, hosting three trials, while Spain participates in four different studies. Italy, France, Netherlands, Belgium, Austria, and Denmark also contribute to this research effort.
Several notable patterns emerge from these trials. Multiple studies focus on HER2-positive tumors, recognizing this specific genetic characteristic as an important target for treatment. Combination therapies appear frequently, with researchers testing various combinations of chemotherapy, targeted therapies, and immunotherapy. The post-surgical setting receives particular attention, with trials specifically designed to prevent cancer recurrence after surgery.
The trials span different treatment scenarios: some target newly diagnosed patients who haven’t received treatment, while others focus on patients whose cancer has progressed despite previous therapy. Several studies include biliary tract cancers more broadly, recognizing the shared characteristics between gallbladder cancer and bile duct cancers.
Immunotherapy features prominently in these trials, either alone or combined with other treatments, reflecting the growing importance of harnessing the immune system to fight cancer. Traditional chemotherapy combinations like gemcitabine and cisplatin continue to be studied, particularly in the post-surgical setting, demonstrating their ongoing relevance in treatment strategies.
