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Study on Capecitabine and Durvalumab for Patients with Removed Biliary Tract Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer known as biliary tract carcinoma, which affects the bile ducts and gallbladder. The study is investigating the effectiveness of two treatments: a combination of capecitabine and durvalumab (also known by its code name MEDI4736), and capecitabine alone. Capecitabine is a medication that comes in the form of film-coated tablets, while durvalumab is given as a concentrate for solution for infusion, which means it is administered through a drip into a vein.

The purpose of the study is to evaluate how well these treatments work in preventing the return of cancer in patients who have had their biliary tract carcinoma surgically removed. The study will follow participants over a period of time to see if the cancer comes back and to assess their overall health and quality of life. Participants will be randomly assigned to receive either the combination of capecitabine and durvalumab or capecitabine alone. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the treatments.

The study will last for several months, with regular visits to monitor the participants' health and response to the treatment. The main goal is to see if the combination of capecitabine and durvalumab can improve the time patients remain free from cancer compared to capecitabine alone. The study will also look at the safety of the treatments and how they affect the participants' quality of life. This research aims to provide valuable information that could help improve treatment options for patients with biliary tract carcinoma in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Randomization
Upon joining the study, you will be randomly assigned to one of two groups. One group will receive a combination of capecitabine and durvalumab, while the other group will receive capecitabine alone. This process is called randomization and ensures that the study results are unbiased.
Step 2
Treatment initiation
If you are in the group receiving both medications, you will start with durvalumab, which is given as an infusion. This means the medication is administered directly into your bloodstream through a vein. The infusion is typically done in a clinical setting.
You will also take capecitabine tablets by mouth. The dosage and frequency will be determined by your healthcare provider based on your specific needs.
Step 3
Treatment with capecitabine
If you are in the group receiving only capecitabine, you will take the medication in the form of tablets. These tablets are taken orally, and the dosage will be specified by your healthcare provider.
Step 4
Regular monitoring
Throughout the study, you will have regular visits with your healthcare team. These visits are important to monitor your health and the effects of the treatment. You may undergo various tests and assessments during these visits.
Step 5
Follow-up
After completing the treatment phase, you will enter a follow-up period. During this time, your health will continue to be monitored to assess the long-term effects of the treatment and to check for any signs of disease recurrence.

Who can join the trial?

14 criteria

Provide written informed consent before any study-related procedures. This means you agree to participate after understanding the study details.
Have adequate organ functions. This means your organs, like your liver and kidneys, are working well enough.
Weigh more than 30 kg (about 66 pounds).
Have a life expectancy of at least 3 months.
If you are a woman who can have children, you must show proof of being post-menopausal or have a negative pregnancy test.
Be part of a social security scheme.
Be willing and able to follow the study rules, including taking medicine by mouth and attending scheduled visits and tests.
Have a type of Biliary Tract Carcinoma (BTC) that has been completely removed by surgery.
No signs of cancer spreading or coming back on a CT scan done less than 4 weeks before starting the study.
Had surgery to remove the primary tumor more than 4 weeks but less than 12 weeks before starting the study treatment.
No dihydropyrimidine dehydrogenase (DPD) deficiency. This is a condition where your body cannot break down certain medicines properly, checked by a specific blood test.
Be at least 18 years old.
Have an ECOG Performance Status of 0-1, which means you are fully active or have some symptoms but can still do light work.
Have a sample of your tumor tissue available for the study.

Who cannot join the trial?

10 criteria

Patients who have not had surgery to remove their biliary tract carcinoma cannot participate. The biliary tract is a system of tubes that carry bile, a fluid made by the liver, to help digest food.
Patients who have another type of cancer, besides biliary tract carcinoma, are not eligible.
Patients who have a serious infection or illness that could interfere with the study are excluded.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients who have had an organ transplant are not eligible.
Patients who are taking certain medications that might interfere with the study treatment cannot participate.
Patients who have a history of severe allergic reactions to similar drugs used in the study are excluded.
Patients who have a condition that affects their immune system, making it weaker, are not eligible.
Patients who have participated in another clinical trial within a certain time frame before this study are excluded.
Patients who have a mental health condition that might make it difficult to follow the study procedures cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
CHRU De Nancy
Vandoeuvre Les Nancy, France
Verified
Centre Hospitalier Departemental Vendee
La Roche sur Yon, France
Verified
Centre Hospitalier Universitaire De Caen Normandie
Caen, France

Trial locations

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Investigated drugs

Capecitabine
is a type of chemotherapy medication that is used to treat certain kinds of cancer, including biliary tract carcinoma. It works by interfering with the growth of cancer cells, slowing down or stopping their spread in the body. In this clinical trial, capecitabine is used as an adjuvant therapy, which means it is given after surgery to help prevent the cancer from coming back.
Durvalumab
is an immunotherapy drug that helps the body's immune system fight cancer. It works by blocking a specific protein that cancer cells use to hide from the immune system. By blocking this protein, durvalumab helps the immune system recognize and attack cancer cells more effectively. In this trial, durvalumab is combined with capecitabine to see if it can improve the chances of staying cancer-free after surgery for biliary tract carcinoma.

What is already known about the treatment

Capecitabine
Capecitabine is a medication taken orally in the form of tablets. It is currently used in medical practice and literature as a chemotherapy drug. The main therapeutic indication for capecitabine in this trial is as an adjuvant therapy for patients with resected biliary tract carcinoma. At the molecular level, capecitabine works by interfering with the DNA production of cancer cells, which prevents them from growing and dividing. It is classified pharmacologically as an antimetabolite.
Durvalumab
Durvalumab is administered through an intravenous infusion, meaning it is given directly into a vein. It is an established medication in the field of immunotherapy and is used in this trial for patients with resected biliary tract carcinoma. The main therapeutic indication is to help the immune system recognize and attack cancer cells. At the molecular level, durvalumab blocks a protein called PD-L1, which cancer cells use to hide from the immune system. It is classified as a monoclonal antibody.

Investigated diseases

Biliary Tract Carcinoma – Biliary tract carcinoma is a type of cancer that originates in the bile ducts, which are responsible for carrying bile from the liver and gallbladder to the small intestine. The disease often begins with changes in the cells lining the bile ducts, leading to the formation of malignant tumors. As the carcinoma progresses, it can cause blockages in the bile ducts, leading to jaundice, abdominal pain, and liver dysfunction. The cancer may spread locally to nearby tissues and organs or metastasize to distant parts of the body. Over time, the disease can lead to significant complications due to its impact on liver function and bile flow. The progression of biliary tract carcinoma can vary, with some cases advancing more rapidly than others.