Ongoing Clinical Trials for Bile Duct Adenocarcinoma
Currently, there is 1 ongoing clinical trial for bile duct adenocarcinoma, testing a new treatment called rilvegostomig in combination with chemotherapy for patients who have undergone surgery. The trial is being conducted across several European countries. (Also known as: Adenocarcinoma of the biliary tract, Cholangiocarcinoma, Gallbladder cancer)
Clinical trial locations
- Belgium
- Denmark
- France
- Germany
- Italy
- Norway
- Poland
- Spain
Study on Rilvegostomig and Chemotherapy for Patients with Biliary Tract Cancer After Surgery
This clinical trial is investigating whether a new treatment called rilvegostomig (also known as AZD2936), when combined with chemotherapy, can help prevent cancer from returning after surgery in patients with bile duct adenocarcinoma. The disease includes cancers in the bile ducts inside or outside the liver, as well as muscle-invasive gallbladder cancer.
Who can participate:
- Patients who have had complete surgical removal of their cancer, confirmed through tissue examination
- Patients who are disease-free according to imaging scans taken within 28 days before starting the study
- Patients who can begin the study within 12 weeks after surgery, with proper healing and removal of any surgical drains
- Patients who have a good level of daily functioning, meaning they are fully active or have some symptoms but can still carry out light work
- A tumor sample from surgery must be available for study purposes
- Both men and women can participate
Who cannot participate:
- Patients who did not have surgery aimed at curing the cancer
- Patients with other unrelated types of cancer
- Patients with serious health conditions that could interfere with the study
- Patients who are pregnant or breastfeeding
- Patients who cannot follow study procedures or attend required visits
- Patients with known allergies to the study drugs
- Patients who have recently participated in another clinical trial
- Patients with recent infections or illnesses that could affect study results
What the trial involves:
Participants will be randomly assigned to receive either rilvegostomig with chemotherapy or a placebo with chemotherapy. Neither the participants nor the researchers will know who receives the actual treatment, which helps ensure unbiased results. The treatment involves both intravenous medications (given directly into the bloodstream) such as gemcitabine, cisplatin, rilvegostomig, and oral medications such as capecitabine and tegafur.
The main goal of the study is to measure how long participants remain free from cancer recurrence, known as recurrence-free survival. Researchers will also look at overall survival (how long participants live after treatment) and how well patients tolerate the treatment. Regular check-ups and imaging tests will be conducted throughout the study to monitor participants’ health and watch for any signs of cancer returning.
About the investigational drugs:
Rilvegostomig is an investigational protein treatment delivered through infusion. It works by targeting specific pathways involved in cancer cell growth and survival. Researchers want to find out if adding rilvegostomig to standard chemotherapy is more effective than chemotherapy alone in preventing cancer from coming back after surgery.
Chemotherapy in this trial includes several drugs commonly used to destroy cancer cells, such as gemcitabine, capecitabine, cisplatin, and tegafur. These medications are given either through infusion or by mouth, depending on the specific drug. The aim is to eliminate any remaining cancer cells after surgery and reduce the risk of recurrence.
The study is estimated to conclude by September 30, 2030, and is being conducted across eight European countries: Poland, Denmark, France, Spain, Belgium, Germany, Norway, and Italy.
Summary
Currently, there is only one ongoing clinical trial for bile duct adenocarcinoma available in Europe. This trial focuses on testing a new investigational treatment called rilvegostomig in combination with standard chemotherapy for patients who have undergone surgery to remove their cancer. The trial is being conducted in multiple European countries, including Poland, Denmark, France, Spain, Belgium, Germany, Norway, and Italy, providing broad access to patients across the continent.
The study specifically targets patients with adenocarcinoma of the biliary tract, which includes both cholangiocarcinoma (bile duct cancer inside or outside the liver) and muscle-invasive gallbladder cancer. The main focus is on preventing cancer recurrence after surgery, which is a significant concern for patients who have undergone treatment.
Participants will need to meet specific health criteria and be able to start treatment within 12 weeks after their surgery. The trial is designed as a double-blind study, meaning neither participants nor researchers know who receives the investigational drug, ensuring that results are as accurate and unbiased as possible.