NCT05822453

Gemcitabine Plus S1 and Tislelizumab in the First Line Therapy of Advanced Biliary Tract Carcinoma

Gemcitabine Plus S1 and Tislelizumab in the First Line Therapy of Advanced Biliary Tract Carcinoma (BTC): a Single Arm, Prospective, Interventional Clinical Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of 1st line therapy with gemcitabine plus S1 and tislelizumab in participants with advanced biliary tract carcinoma (BTC).

Conditions

• Biliary Tract Carcinoma

Interventions

Type	Name	Description
DRUG	Gemcitabine	Gemcitabine (1000 mg/m2) will be administered by IV infusion on Day 1and Day 8 of each 21-day cycle
DRUG	S1	S1 (60 mg/day if body surface area \< 1.25 m2, 80 mg/day if body surface area = 1.25\~1.50 m2) will be administered by PO on Day 1 \~ 14 of each 21-day cycle
DRUG	Tislelizumab	Tislelizumab (200 mg) will be administered by IV infusion on Day 1 of each 21-day cycle

Timeline

• Start date: 2023-04-30
• Primary completion: 2025-04-30
• Completion: 2026-04-30
• First posted: 2023-04-20
• Last updated: 2023-04-20

Locations

1 site across 1 country: China