Durvalumab With Chemotherapy as First Line Treatment in Patients With Advanced Biliary Tract Cancers (aBTCs)

To join this study, you would need to have advanced bile duct cancer (including cancers of the bile ducts, gallbladder, or ampulla of Vater) that cannot be removed by surgery. You also need to be at least 18 years old and in reasonably good health, meaning you can carry out most daily activities, even if you sometimes feel tired. Patients with some specific health conditions, like severe heart problems, uncontrolled high blood pressure, certain autoimmune diseases, or other active infections, would not be able to take part.

Your body's organs and blood would need to be working well, and you would need to have measurable tumours that doctors can track. For women who could become pregnant, a negative pregnancy test is required, and both men and women would need to agree to use effective birth control during the study.

Excluding certain conditions helps make sure the study is as safe as possible for participants and that the results clearly show the effects of the new treatment. Your doctor will carefully review all your medical history to see if this study is right for you.

If you decide to take part in this study, the first step is a 'screening period,' which lasts up to 28 days. During this time, you'll have tests and checks to confirm you are eligible. If you qualify, you'll enter the 'treatment period.' This involves receiving up to 8 cycles of a chemotherapy regimen combined with durvalumab. Each 'cycle' typically involves a set schedule of treatments over a few weeks.

After the main chemotherapy cycles, if your treatment is working well, you might continue into a 'maintenance treatment' period. This usually means continuing with durvalumab, sometimes still with some chemotherapy drugs. Throughout the study, you'll have regular hospital visits for treatment, blood tests, scans, and check-ups to monitor your health and how the treatment is working. Once treatment finishes, there will be a 'safety and survival follow-up' period, where doctors will continue to check on your health over time, even without active treatment. The total duration of your participation, including follow-up, can be quite long, potentially several years.