Study on Gemcitabine, Cisplatin, Nab-paclitaxel, and Cemiplimab for Advanced Biliary Tract Cancer

Sponsor: Columbia University

Sponsor score: 40

ClinicalTrials ID:NCT07433673

This clinical trial is exploring whether a combination of chemotherapy drugs and an immunotherapy drug can shrink tumors in patients with advanced biliary tract cancer, making surgery possible.

Patient Parameters

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Program Overview

The study aims to test if combining chemotherapy drugs (gemcitabine, cisplatin, and nab-paclitaxel) with an immunotherapy drug (cemiplimab) can shrink tumors in patients with advanced biliary tract cancer, allowing for surgical removal. This combination has not been tried before, and cemiplimab is being used in a new way for this type of cancer. The goal is to find new treatments that can make surgery possible, as it is currently the only potential cure for this cancer.

Description

This study is testing a new combination of treatments for advanced biliary tract cancer, which affects the bile ducts and gallbladder. The treatment includes three chemotherapy drugs—gemcitabine, cisplatin, and nab-paclitaxel—along with an immunotherapy drug called cemiplimab. While these drugs have been used separately or in different combinations before, this is the first time they are being used together for this type of cancer.

The goal is to see if this combination can shrink tumors enough to make surgery possible, as surgery is the only way to potentially cure this cancer. Cemiplimab is already approved for other types of cancer, but its use in this study is experimental. The study is important for patients with advanced biliary tract cancer that hasn't spread to other parts of the body, as new treatments are needed to improve outcomes.

Eligibility Criteria

Inclusion Criteria

Diagnosed with biliary tract adenocarcinoma, including intra- or extra-hepatic and gallbladder cancer.
Cancer must be advanced and cannot be removed by surgery, but has not spread to distant parts of the body.
Must be 18 years or older.
Have not received any prior treatment for biliary tract cancer.
Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
Have a life expectancy of more than 3 months.
Have measurable disease, meaning at least one tumor that can be accurately measured.
Have adequate blood cell counts and organ function based on specific medical tests.
If you have hepatitis B or C, the infection must be under control.
If you are HIV positive, the infection must be under control with a CD4+ T cell count of at least 200 cells/mm3.
Women must not be pregnant and must agree to use effective contraception during and after the study.
Men must agree to use contraception during and after the study.
Must understand and agree to the study requirements, including signing a consent form.

Exclusion Criteria

Have a different type of cancer than biliary tract adenocarcinoma.
Cancer that can be surgically removed or has spread to distant parts of the body.
Have received prior chemotherapy, investigational therapy, or immune therapy for biliary tract cancer.
Have had previous radiation therapy for the biliary tract tumor.
Have had major surgery or significant injury within 14 days before starting the study.
Have an active autoimmune disease or immune deficiency.
Have a history of severe allergic reactions to similar drugs used in the study.
Have significant heart disease or uncontrolled medical conditions.
Have an active infection requiring treatment.
Are pregnant or breastfeeding, or planning to become pregnant or father a child during the study.
Have a history of psychiatric or substance abuse disorders that would interfere with the study.
Are unlikely to comply with the study procedures and requirements.

Locations

FACILITY	ZIP	CITY	STATE
Columbia University Irving Medical Center	10032	New York	New York

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