Ongoing Clinical Trials for Biliary Adenoma
There is currently 1 ongoing clinical trial for biliary adenoma, investigating a combination of immunotherapy and chemotherapy treatments in an adjuvant setting. This trial is being conducted in Germany and focuses on preventing cancer recurrence after surgical removal of biliary tract cancer.
Clinical trial locations
Study of Durvalumab, Tremelimumab, and Capecitabine for Patients with Biliary Tract Cancer in an Adjuvant Setting
This clinical trial is investigating a combination of treatments aimed at preventing cancer from returning after surgery. The study takes place in Germany and focuses on patients who have had biliary tract cancer successfully removed through surgery.
Main inclusion criteria:
- Adults aged 18 years or older who can provide written consent to participate
- Confirmed diagnosis of biliary tract cancer that has been surgically removed without signs of spreading to other parts of the body
- Surgery must have been performed within the last 16 weeks
- Ability to carry out daily activities without significant help (performance status of 1 or less)
- Life expectancy of at least 12 weeks
- Adequate blood cell counts, liver function, and kidney function
- Normal blood clotting ability
- Willingness to use effective birth control during the study if of reproductive age, with negative pregnancy test for women before starting
Main exclusion criteria:
- Having a different type of cancer other than biliary tract cancer
- Being pregnant or breastfeeding
- Recent participation in another clinical trial
- Medical conditions that could interfere with the study or make participation unsafe
- Unable to follow study procedures or provide informed consent
Focus and goal of the trial:
The main goal of this study is to assess how well a combination of treatments works in preventing cancer from coming back after surgery. The trial will monitor participants over time to evaluate recurrence-free survival at 12 months, as well as overall survival and quality of life. Researchers will conduct regular check-ups and tests, including physical exams, blood tests, and imaging studies. The study also aims to gather information about the safety of these treatments and their impact on liver function. Tissue and blood samples will be collected for future research to help identify potential biomarkers that may predict treatment outcomes.
Investigational drugs being tested:
The study uses three medications in combination:
Durvalumab is an immunotherapy drug given through intravenous infusion. It works by blocking a protein called PD-L1 that prevents the immune system from attacking cancer cells. By blocking this protein, durvalumab allows the immune system to better detect and fight cancer cells.
Tremelimumab is another immunotherapy medication administered through intravenous infusion. It enhances the immune system’s ability to fight cancer by targeting a protein called CTLA-4 that can suppress the immune response. This helps boost the body’s natural defenses against cancer cells.
Capecitabine is a chemotherapy drug taken orally in tablet form. It interferes with the growth of cancer cells by affecting their ability to divide and multiply. In the body, capecitabine is converted into 5-fluorouracil, which disrupts DNA synthesis in cancer cells.
Participants will receive either the combination of durvalumab and tremelimumab with capecitabine or without capecitabine. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatments. The study is expected to conclude by April 2025.
Summary
Currently, there is one active clinical trial for biliary adenoma, located in Germany. This trial focuses on an adjuvant treatment approach, meaning it aims to prevent cancer recurrence after surgical removal. The study combines two immunotherapy drugs, durvalumab and tremelimumab, with the chemotherapy drug capecitabine. This combination approach reflects current trends in cancer treatment that seek to harness the power of the immune system alongside traditional chemotherapy. The trial’s primary endpoint is to measure recurrence-free survival at 12 months, which will help determine whether this combination therapy can effectively keep cancer from returning after surgery. Patients interested in participating must meet specific health criteria and have had their cancer surgically removed within the past 16 weeks.
