Study on Durvalumab with Chemotherapy for Patients with Advanced Biliary Tract Cancer

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What is this study about?

This clinical trial is focused on studying the treatment of Advanced Biliary Tract Cancers, which are cancers that occur in the bile ducts, gallbladder, or the area where the bile duct and pancreatic duct meet. The study will use a combination of medications, including Durvalumab (also known as MEDI4736), which is a type of medication that helps the immune system fight cancer, and chemotherapy drugs such as Gemcitabine, Carboplatin, Oxaliplatin, Cisplatin, and Infliximab. These medications are given through an infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of this study is to assess the safety of using Durvalumab in combination with chemotherapy for patients who have not received prior treatment for their advanced biliary tract cancer. Participants in the study will receive these treatments over a period of time, and their health will be monitored closely to observe any effects of the treatment. The study will also include a group of participants who will receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatment.

Throughout the study, participants will undergo regular health check-ups and assessments to monitor their response to the treatment. The study aims to provide valuable information on how well the combination of Durvalumab and chemotherapy works in treating advanced biliary tract cancers and to ensure the safety of the treatment for patients. The study is expected to continue until March 2025, with recruitment having started in September 2023.

1 initial visit and consent

Upon joining the study, you will have an initial visit where you will be asked to provide informed consent. This means you will sign a document that explains the study, its risks, and benefits, confirming your willingness to participate.

During this visit, you will undergo a series of tests to confirm your eligibility, including a physical examination and blood tests. These tests ensure that you meet the study’s requirements.

2 treatment initiation

Once eligibility is confirmed, you will begin the treatment phase. You will receive durvalumab combined with chemotherapy drugs such as gemcitabine and possibly others like carboplatin or cisplatin.

Durvalumab will be administered through an intravenous infusion, which means it will be given directly into your vein. The frequency and dosage will be determined by the study protocol and your healthcare provider.

3 ongoing treatment and monitoring

Throughout the study, you will continue to receive the treatment as scheduled. Regular visits will be required to monitor your health and the effects of the treatment.

You will undergo periodic assessments, including blood tests and imaging studies, to evaluate the treatment’s impact on your condition.

4 follow-up and final assessment

After completing the treatment phase, you will have follow-up visits to assess your overall health and any long-term effects of the treatment.

These visits will help determine the treatment’s effectiveness and gather information for the study’s final analysis.

Who Can Join the Study?

Participant must be at least 18 years old at the time of screening.
Participant must weigh more than 30 kg (about 66 pounds).
Both males and females can participate.
Women who can have children must have a negative pregnancy test before joining the study.
Women who can have children must be either one year post-menopausal, surgically sterile, or using a highly effective form of birth control during the study and for a period after the study ends.
Men who are sexually active with women who can have children must be surgically sterile or use an acceptable method of contraception during the study and for a period after the study ends.
Participant must be able to give informed consent, which means they understand the study and agree to participate.
Participant must have a type of cancer called Advanced Biliary Tract Cancer that cannot be removed by surgery.
Participants with cancer that has not been treated before are eligible if the cancer cannot be removed by surgery or has spread to other parts of the body.
Participants who have had surgery or other treatments aimed at curing the cancer are allowed, even if the cancer has come back.
Participant must have a WHO/ECOG Performance Status of 0 to 2, which is a measure of their ability to perform daily activities.
Participant must have at least one measurable lesion as defined by specific criteria.
Participants with Hepatitis B infection must be on antiviral therapy to control the virus before joining the study and continue it during the study.
Participant must have adequate organ and bone marrow function, which includes specific levels of blood cells and liver and kidney function.
Participant must have a life expectancy of at least 12 weeks.

Who Cannot Join the Study?

Patients with any other type of cancer besides Advanced Biliary Tract Cancers cannot participate.
Patients who have had a severe allergic reaction to any of the study drugs or similar drugs cannot participate.
Patients with serious heart problems, such as heart failure or a recent heart attack, cannot participate.
Patients with uncontrolled high blood pressure cannot participate.
Patients with active infections, including hepatitis B, hepatitis C, or HIV, cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have received another investigational drug within the last 4 weeks cannot participate.
Patients with a history of autoimmune diseases, which are conditions where the immune system attacks the body, cannot participate.
Patients with brain metastases, which are cancer cells that have spread to the brain, cannot participate unless they have been treated and are stable.
Patients who have had a major surgery within the last 4 weeks cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
IRCCS Humanitas Research Hospital	Rozzano	Italy
Medizinische Hochschule Hannover	Hanover	Germany
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Hospital Paul Brousse	Villejuif	France
Hopital Saint Eloi	Montpellier	France
Centre De Lutte Contre Le Cancer Eugene Marquis	Rennes	France
Virgen del Rocío University Hospital	Sevilla	Spain
Klinikum Chemnitz gGmbH	Chemnitz	Germany
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Universita’ Di Pisa	Pisa	Italy
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hopital Beaujon	Clichy	France
Hospital Edouard Herriot	Lyon	France
Hospital Universitario 12 De Octubre	Madrid	Spain
Krankenhaeuser Landkreis Freudenstadt gGmbH	Freudenstadt	Germany
Avsjtde Olbfjdzuzdk Ocrjwtcq Rsdmdxt Vjjat Slcho Cnzrftwh	Palermo	Italy
Herzpwkb Vaqy dwqbnryj	Barcelona	Spain
Iqtvpkrg Oitdztsaqm Vzfizr	Castelfranco Veneto	Italy
Cnjwjn Hgwvnaceuso Uvfgbexndnjwv Dx Dpowy	Dijon	France
Aydlwxz Ohcobooeubp Uocjoxanzkjzb Ofxealka Rkqenkd	Foggia	Italy
Kstbrysa dqf Uxhxzhqfujfs Mzrhcfgt Agh	Munich	Germany

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	01.09.2023
Germany	Not yet recruiting	01.09.2023
Italy	Not yet recruiting	01.09.2023
Spain	Not yet recruiting	01.09.2023

Trial locations

Investigated drugs:

Durvalumab is a type of medication known as an immunotherapy. It works by helping your immune system recognize and attack cancer cells. In this trial, durvalumab is used to help treat advanced biliary tract cancers by boosting the body’s natural defenses to fight the cancer.

Gemcitabine-based chemotherapy is a treatment that uses drugs to kill cancer cells or stop them from growing. Gemcitabine is a common chemotherapy drug that is often used to treat various types of cancer, including biliary tract cancers. In this trial, it is combined with durvalumab to see if the combination is more effective in treating the cancer than using chemotherapy alone.

Advanced Biliary Tract Cancers – Biliary tract cancers originate in the bile ducts, gallbladder, or ampulla of Vater. These cancers are characterized by the abnormal growth of cells in the biliary system, which can lead to blockages and impaired bile flow. As the disease progresses, it may invade nearby tissues and organs, causing symptoms such as jaundice, abdominal pain, and weight loss. The cancer can spread to distant parts of the body, a process known as metastasis. Advanced stages of the disease often involve significant tumor growth and spread beyond the original site. The progression of these cancers can lead to complications affecting liver function and overall health.

Trial ID:

2022-502043-35-00

Protocol code:

D4191C00140

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Durvalumab with Chemotherapy for Patients with Advanced Biliary Tract Cancer

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