NCT07433673

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The purpose of this study is to combine chemotherapy that has previously been shown to have activity in patients with biliary tract cancer with a drug that stimulates the body's immune system against cancer cells (immunotherapy). Previously, the combination of gemcitabine and cisplatin with immunotherapy has been shown to prolong life in patients with advanced biliary tract cancer. Adding nab-paclitaxel, another chemotherapy, to gemcitabine and cisplatin, has also been shown to prolong life in some patients with advanced biliary tract cancer. However, all four of these drugs have not before been combined. Cemiplimab is being used in an investigational manner (not for the purpose that it was approved for) in this research study. This means that cemiplimab has been approved by the Food and Drug Administration (FDA) for use in advanced or metastatic cutaneous squamous cell carcinoma, basal cell carcinoma, and non-small cell lung cancer, but has not been approved for locally advanced biliary tract cancer that cannot be surgically removed. Since surgery is the only way to potentially cure this cancer, new treatments are needed that can shrink inoperable tumors enough to make surgery possible. This is especially important for patients with advanced biliary tract cancer that hasn't spread to other parts of the body.

Conditions

• Colon and Rectal Cancer

Interventions

Type	Name	Description
DRUG	Cemiplimab	intravenous 300mg

Timeline

• Start date: 2026-08-01
• Primary completion: 2028-01-01
• Completion: 2029-01-01
• First posted: 2026-02-25
• Last updated: 2026-02-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study