Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

ADJUBIL - A Phase II study of immunotherapy with durvalumab and tremelimumab in combination with capecitabine or without capecitabine in ADJUvant situation for BILiary tract cancer

This research study, called ADJUBIL, is for people with biliary tract cancer who have had surgery to remove their tumour. Doctors want to find out if adding new immunotherapy drugs, durvalumab (IMFINZI) and tremelimumab, with or without standard chemotherapy (capecitabine), can help stop the cancer from returning. Immunotherapy uses your body's immune system to fight cancer. The study will check how well these treatments prevent the cancer from coming back within 12 months, how long people live, and if the treatments are safe. It also looks at how the treatments affect patients' quality of life. Participants will be aged 18 or over, and both men and women can take part. The goal is to discover better ways to keep biliary tract cancer from coming back after surgery.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH

Enrolment target

Start

20 Sep 2024

Biliary tract cancer

What is this study about?

This study, called ADJUBIL, is for people who have been diagnosed with a type of cancer known as biliary tract cancer and have already had an operation to remove it. Even after surgery, there's a chance the cancer could return, so doctors are always looking for better ways to prevent this.

In this study, researchers want to see if combining a newer type of treatment called immunotherapy with standard treatments can help. Immunotherapy drugs, like durvalumab (also known as IMFINZI) and tremelimumab, work by helping your body's own immune system find and fight cancer cells. The study will test these immunotherapy drugs either on their own or together with a common chemotherapy drug called capecitabine.

The main goal is to find out if these new combinations can keep the cancer from coming back for at least 12 months after starting treatment. The researchers will also be looking at how long people live overall, how safe the treatments are, and if they affect your general well-being and quality of life. By collecting blood and tissue samples, they hope to learn more about why some treatments work better for certain people, which could lead to more personalised treatments in the future.

Key takeaways

This study is for people with biliary tract cancer who have had surgery.
It tests new immunotherapy drugs (durvalumab, tremelimumab) with or without chemotherapy (capecitabine).
The main goal is to stop the cancer from returning.
The study also looks at safety, overall survival, and quality of life.
Participants must be 18 or older; both men and women can join.

Who may be eligible?

To be able to join this study, people generally need to be at least 18 years old. There's no upper age limit, meaning older adults can also take part.

Both men and women are welcome to participate in this research. The study is specifically for people who have been diagnosed with biliary tract cancer and have recently had surgery to remove their cancer.

Beyond these general points, there will be other medical checks and criteria that the doctors will look at to make sure the study is right and safe for you. These might include your general health, other medical conditions, and previous treatments. Your doctor will discuss all these details with you.

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?
Do you have biliary tract cancer?
Have you recently had surgery to remove your cancer?
Are you willing to discuss your full medical history with the study team?
Are you able to attend regular hospital visits for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive one of the specific treatment combinations being tested, which includes immunotherapy drugs (durvalumab and tremelimumab) and possibly capecitabine. You would have regular appointments for check-ups, blood tests, and scans to monitor your health and how the treatment is working. These visits are important to track the cancer, manage any side effects, and assess your general well-being. The exact schedule of visits and treatments would be explained in detail by the study team. Follow-up would continue for a period after your main treatment ends to see if the cancer returns and to check your long-term health. The total duration of participation, including treatment and follow-up, would be discussed with you.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that you might receive a new treatment that could be more effective in preventing your cancer from returning than standard approaches. However, there's no guarantee the treatment will work for everyone, and it's also possible that it may not be better than existing treatments. Like all medications, the study drugs can have side effects, which range from mild to severe, and they will be carefully monitored. You will be given detailed information about these potential risks. Remember, taking part in a study is always voluntary, and you have the right to withdraw at any time, for any reason, without it affecting your future medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What is biliary tract cancer?

Biliary tract cancer is a rare type of cancer that starts in the bile ducts, which are tubes that carry digestive fluid (bile) from your liver to your small intestine.

What is immunotherapy?

Immunotherapy is a treatment that helps your body's own immune system fight cancer. It works by making your immune cells better at finding and destroying cancer cells.

What is the purpose of this study?

The study aims to see if combining new immunotherapy drugs with or without standard chemotherapy can help prevent biliary tract cancer from coming back after surgery and improve long-term outcomes.

Will I definitely get the new drugs if I join?

Yes, if you join this study, you will receive one of the experimental treatment combinations being tested, which includes the immunotherapy drugs.

What does 'recurrence-free survival' mean?

'Recurrence-free survival' means the length of time after treatment that a person lives without the cancer coming back.