Ongoing Clinical Trials for Biliary Tract Surgery
Currently, there is 1 ongoing clinical trial investigating treatments for patients who have undergone surgery for biliary tract cancer. This trial is exploring a combination of immunotherapy and chemotherapy drugs to help prevent cancer from returning after surgery. The study is being conducted in Germany and aims to improve treatment options and outcomes for patients with this condition.
Clinical trial locations
Study of Durvalumab, Tremelimumab, and Capecitabine for Patients with Biliary Tract Cancer in an Adjuvant Setting
This clinical trial is examining whether a combination of immunotherapy and chemotherapy can help prevent cancer from returning in patients who have had surgery to remove biliary tract cancer. The trial is testing three medications together: durvalumab, tremelimumab, and capecitabine.
Main focus and goal: The primary purpose of this study is to determine whether this combination of treatments can keep cancer from coming back after surgery. Researchers will monitor participants for 12 months to see if the cancer returns and will also track overall survival rates and quality of life. The study will collect tissue and blood samples to help identify markers that might predict how well the treatment works for different patients. Some participants will receive a placebo for comparison purposes.
Investigational drugs being tested:
- Durvalumab: An immunotherapy drug given through an intravenous infusion that helps the immune system recognize and attack cancer cells by blocking a protein called PD-L1
- Tremelimumab: Another immunotherapy drug given through intravenous infusion that boosts the immune system’s response by blocking a protein called CTLA-4
- Capecitabine: A chemotherapy pill that interferes with cancer cell growth by disrupting their ability to divide and multiply
Who can participate – main inclusion criteria:
- Adults aged 18 years or older
- Confirmed diagnosis of biliary tract cancer that has been surgically removed within the last 16 weeks, with no signs of cancer spreading to other parts of the body
- Ability to carry out daily activities without significant help (performance status of 1 or less)
- Life expectancy of at least 12 weeks
- Adequate blood, liver, and kidney function, including normal levels of white blood cells, platelets, hemoglobin, and appropriate levels of bilirubin, liver enzymes, and creatinine
- Normal blood clotting ability
- For those of reproductive age, willingness to use effective birth control during the study and for a period afterwards; women must have a negative pregnancy test before starting
- Ability to provide written consent and follow study procedures
Who cannot participate – main exclusion criteria:
- Patients with a different type of cancer other than biliary tract cancer
- Those who are pregnant or breastfeeding
- Patients who have recently participated in another clinical trial
- Those with certain medical conditions that could make participation unsafe or interfere with study results
- Patients unable to follow study procedures or provide informed consent
The study involves regular check-ups and tests throughout the treatment period to monitor health and treatment effects. Participants will receive the medications according to the study protocol, with durvalumab and tremelimumab given through IV infusion and capecitabine taken as an oral medication. The trial is expected to conclude in April 2025.
Summary
Currently, there is one active clinical trial available for patients who have undergone surgery for biliary tract cancer. This trial is being conducted in Germany and focuses on preventing cancer recurrence using a combination approach of two immunotherapy drugs and one chemotherapy drug. The study represents an important investigation into adjuvant treatment options, which are treatments given after surgery to reduce the risk of cancer returning.
The trial is particularly notable for its focus on combining immune checkpoint inhibitors (durvalumab and tremelimumab) with traditional chemotherapy (capecitabine), representing a modern approach to cancer treatment that aims to harness both the body’s immune system and direct cancer-fighting medications. Patients interested in participating should have had their surgery within the past 16 weeks and meet specific health criteria to ensure safe participation.
