Study of Durvalumab with Gemcitabine and Cisplatin for Patients with Advanced Biliary Tract Cancer

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What is this study about?

This clinical trial is focused on studying the effectiveness of a treatment for patients with advanced biliary tract cancer, which includes cancers of the bile ducts and gallbladder. The study will compare the effects of a medication called Durvalumab (also known by its code name MEDI4736) in combination with two chemotherapy drugs, Gemcitabine and Cisplatin, against a combination of Gemcitabine and Cisplatin with a placebo. Durvalumab is a type of medication that helps the immune system fight cancer cells.

The purpose of the study is to evaluate how well the combination of Durvalumab with Gemcitabine and Cisplatin works compared to the combination with a placebo in terms of overall survival, which means how long patients live after starting the treatment. The study will involve patients who have not received any prior treatment for their advanced biliary tract cancer. Participants will receive the treatment through an intravenous infusion, which means the medication is given directly into a vein.

Throughout the study, researchers will monitor the patients’ health and response to the treatment. They will look at various factors, including how long the cancer stays under control, the response rate to the treatment, and the duration of the response. The study will also assess the quality of life of the participants, including physical function and symptoms like fatigue and appetite loss. The trial is expected to continue until March 2025, with recruitment starting in April 2024.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, such as having advanced biliary tract cancer that is not treatable with surgery or has returned after previous treatment.

The study involves patients who have not received prior treatment for their advanced condition.

2 treatment initiation

The treatment phase begins with the administration of medications. The main drugs used are gemcitabine and cisplatin, both given through a vein (intravenous).

In one group, durvalumab is added to the treatment, also administered intravenously. The other group receives a placebo instead of durvalumab.

3 medication schedule

The treatment cycle typically involves receiving gemcitabine and cisplatin on specific days over a period of weeks, followed by a rest period.

Durvalumab or placebo is administered on a regular schedule, often every few weeks, depending on the specific protocol of the study.

4 monitoring and assessments

Throughout the study, regular assessments are conducted to monitor the response to treatment. This includes imaging tests to evaluate the size of the cancer and blood tests to check overall health.

Quality of life is also assessed using questionnaires that address physical function, symptoms like fatigue, and other health-related aspects.

5 end of treatment

The treatment continues until the study’s end date or until it is determined that the treatment is no longer effective or safe.

The primary goal is to assess overall survival, while secondary goals include progression-free survival and response to treatment.

Who Can Join the Study?

You must have a confirmed diagnosis of advanced biliary tract cancer, which includes cancers of the bile ducts or gallbladder. These cancers should be either unresectable (cannot be removed by surgery) or metastatic (have spread to other parts of the body).
Your cancer should not have been treated before if it is unresectable or metastatic at the time of diagnosis.
If your cancer has come back after surgery meant to cure it, or after additional treatments like chemotherapy or radiation, it must have been more than 6 months since those treatments were completed.
You should have a WHO/ECOG PS (World Health Organization/Eastern Cooperative Oncology Group Performance Status) of 0 or 1. This is a scale that measures your ability to perform daily activities, where 0 means you are fully active and 1 means you are restricted in physically strenuous activity but can carry out light work.
Both men and women can participate in the study.
The study is open to adults, which typically means you need to be at least 18 years old.

Who Cannot Join the Study?

Patients who have already received treatment for their advanced biliary tract cancers cannot participate.
Individuals with other serious health conditions that might interfere with the study are not eligible.
Pregnant or breastfeeding women are excluded from the study.
Patients who are unable to follow the study procedures or attend the required visits are not allowed to join.
Anyone with a history of allergic reactions to the study medications cannot take part.
Individuals with certain infections or diseases that could affect the study results are not eligible.
Patients who are participating in another clinical trial at the same time are excluded.
People with mental health conditions that might affect their ability to consent or participate are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Acibadem City Clinic Diagnostic And Consultation Center Tokuda EAD	Sofia	Bulgaria

Other Sites

Site Name	City	Country
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Hopital Beaujon	Clichy	France
Mbal Za Zhensko Zdrave Nadezhda OOD	Sofia	Bulgaria
Universita’ Degli Studi Di Verona	Verona	Italy
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Wvkskpldjwv Wkibzuywiublzbgiqzti Cwzyzol Oszpeflfq I Tviycziherbzd Ij Mdvlptbwzry W Liiof	Lodz	Poland
Cvoqia Hxtnnpngirl Ukibymmhhzxui Dp Dloft	Dijon	France
Uuznrcucdsaast Clkqlsv Khhxjkpbg	Gdansk	Poland

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	05.04.2024
France	Not recruiting	05.04.2024
Italy	Not recruiting	05.04.2024
Poland	Not recruiting	05.04.2024

Trial locations

Durvalumab is a medication used in this trial to help the immune system fight cancer. It works by blocking a specific protein that can stop the immune system from attacking cancer cells, allowing the body to better target and destroy these cells.

Gemcitabine is a chemotherapy drug used to treat various types of cancer, including biliary tract cancer. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing.

Cisplatin is another chemotherapy medication used in this trial. It helps to kill cancer cells by damaging their DNA, which stops them from multiplying and spreading.

Biliary Tract Cancer – Biliary tract cancer is a rare type of cancer that occurs in the bile ducts, gallbladder, or ampulla of Vater. It often begins in the cells lining the bile ducts and can spread to other parts of the body. The disease may cause symptoms such as jaundice, abdominal pain, and weight loss as it progresses. Biliary tract cancer is typically diagnosed at an advanced stage due to its subtle early symptoms. The progression of the disease can lead to blockages in the bile ducts, affecting liver function. It is considered a challenging cancer to treat due to its location and the complexity of the biliary system.

Trial ID:

2023-507405-34-00

Protocol code:

D933AC00001

NCT ID:

NCT03875235

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Durvalumab with Gemcitabine and Cisplatin for Patients with Advanced Biliary Tract Cancer

What is this study about?

Who Can Join the Study?

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