RecruitingPhase 2NCT07433673

Gemcitabine, Cisplatin, Nab-paclitaxel (GAP) and Cemiplimab for Locally Advanced Biliary Tract Cancer (BTC)

A Phase 2 Single-arm Study of Cemiplimab, Added to Typical Chemotherapy (Gemcitabine, Cisplatin, Nab-paclitaxel) for Down-staging of Locally Advanced, Unresectable Biliary Tract Cancer


Sponsor

Columbia University

Enrollment

20 participants

Start Date

Aug 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This study is being conducted to find out if treatment with gemcitabine, cisplatin, nab-paclitaxel, and cemiplimab can shrink previously inoperable tumors enough for surgery.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of gemcitabine, cisplatin, nab-paclitaxel (chemotherapy drugs) plus cemiplimab (an immunotherapy drug) as treatment for locally advanced biliary tract cancer — which includes cancers of the bile ducts and gallbladder that cannot be surgically removed. **You may be eligible if...** - You have been diagnosed with biliary tract adenocarcinoma (intra- or extra-hepatic, or gallbladder) confirmed by biopsy - Your cancer is locally advanced and cannot be surgically removed but has not spread to distant organs - You have not yet received chemotherapy for this advanced disease - You are in reasonably good health and able to carry out daily activities **You may NOT be eligible if...** - Your cancer has spread to distant organs (metastatic disease) - You have already received chemotherapy for advanced disease - You have a history of autoimmune disease or are on immune-suppressing drugs - You have significant liver, kidney, or heart problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCemiplimab

intravenous 300mg


Locations(1)

Columbia University Irving Medical Center

New York, New York, United States

View Full Details on ClinicalTrials.gov

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NCT07433673


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