PRODIGE 76-IMMUNOBILADJ: Capecitabine plus durvalumab or capecitabine alone as adjuvant therapy in patients with resected biliary tract carcinoma. A non-comparative randomized phase II study
This research study, called PRODIGE 76-IMMUNOBILADJ, is for people who have had surgery for bile duct cancer. After surgery, some patients will receive a standard chemotherapy medicine called capecitabine. Other patients will receive capecitabine along with a different medicine called durvalumab (also known as Imfinzi), which helps the body's immune system fight cancer. The study wants to find out if adding durvalumab to capecitabine helps patients stay free from cancer for longer after their surgery. Researchers will also look at how safe the treatments are, patients' overall health, and their quality of life. This is a Phase II study, meaning it's an early stage of testing new treatments to see if they are promising.
At a glance
What is this study about?
This study is for people who have been diagnosed with a type of cancer called biliary tract carcinoma, more commonly known as bile duct cancer, and have had surgery to remove it. After surgery, there's always a chance that some cancer cells might be left behind, even if they can't be seen. To help prevent the cancer from coming back, doctors often recommend additional treatment, known as 'adjuvant therapy'.
In this study, researchers are comparing two different adjuvant treatments. One treatment is a standard chemotherapy medicine called capecitabine. The other treatment combines capecitabine with a newer medicine called durvalumab (also known by its brand name, Imfinzi). Durvalumab is an immunotherapy drug, which means it works by helping your body's own immune system recognise and fight cancer cells more effectively.
The main aim of the study is to see if adding durvalumab to capecitabine helps patients stay free from cancer for a longer period of time after their surgery, specifically looking at how many people are cancer-free at 18 months. They will also be closely watching for any side effects from the treatments, checking patients' overall survival, and seeing how the treatments affect their day-to-day lives and general well-being.
Key takeaways
- Tests a new combination treatment for bile duct cancer after surgery.
- Compares standard chemotherapy (capecitabine) with chemotherapy plus immunotherapy (durvalumab/Imfinzi).
- Aims to see if the new combination helps prevent cancer from coming back.
- Monitors safety, quality of life, and how long people stay cancer-free.
- Open to adults aged 18 and over, both men and women, who have had surgery for bile duct cancer.
Who may be eligible?
To join this study, you must be at least 18 years old. There are no upper age limits, so adults of any age can be considered. Both men and women are welcome to take part.
You would need to have been diagnosed with bile duct cancer (biliary tract carcinoma) and have recently had surgery to remove the tumour. There will be other specific medical checks and tests to make sure that the treatment would be safe and appropriate for your particular health situation.
Your study doctor will discuss all the detailed requirements with you to confirm if this study is suitable for your individual circumstances.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Have you been diagnosed with bile duct cancer?
- Have you recently had surgery to remove the bile duct cancer?
- Are you able to attend regular hospital visits and appointments?
- Are you willing to potentially receive either of the study treatments at random?
What does participation involve?
If you decide to take part in this study, you'll be randomly assigned to one of two treatment groups, like flipping a coin, so neither you nor your doctor can choose which treatment you receive. One group will get capecitabine alone, and the other will get capecitabine plus durvalumab (Imfinzi). Both medicines are given over a period of time, as prescribed by the study doctors.
You will have regular hospital visits for treatment and check-ups. These visits will involve physical examinations, blood tests, and scans to monitor your health and how the treatment is working. The study team will also ask you questions about your general well-being and any side effects you might experience. The total duration of your involvement in the study, including follow-up appointments after treatment, will be explained by the study team, but it typically involves monitoring for some time after your treatment finishes.
Potential risks and benefits
Locations (1)
- —UnverifiedFrance
Common questions
What is bile duct cancer?
Bile duct cancer is a rare type of cancer that starts in the tubes that carry digestive fluid (bile) from the liver to the small intestine.
What is chemotherapy?
Chemotherapy uses strong medicines to kill cancer cells, often by stopping them from growing and dividing. Capecitabine is a common chemotherapy drug.
What is immunotherapy?
Immunotherapy is a type of cancer treatment that helps your own immune system fight cancer. Durvalumab (Imfinzi) is an immunotherapy drug.
Why is this study being done?
This study aims to find out if adding an immunotherapy drug to standard chemotherapy can help people with bile duct cancer stay cancer-free for longer after surgery.
What does a 'Phase II' study mean?
A Phase II study is an early stage of clinical research that looks at whether a new treatment is effective and safe. It helps decide if it's promising enough for further, larger studies.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.