NCT04172402

NGS as the First-line Treatment in Advanced Biliary Tract Cancer

A Study of Nivolumab Combination Gemcitabine and S1 as the First-Line Treatment in Patients With Advanced Biliary Tract Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: National Health Research Institutes, Taiwan · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

To evaluate disease objective response rate (ORR) of nivolumab in combination with gemcitabine and TS1 in patients with advanced biliary tract cancer

Detailed description

The primary endpoint will be evaluating overall response rate (ORR) of nivolumab in combination with gemcitabine and TS-1 in patients with advanced BTC. Simon's two-stage design will be used. If there are 3 or fewer subjects with controlled disease in these 19 patients, the study will be stopped. Otherwise, 25 additional patients will be accrued for a total of 44. The null hypothesis will be rejected if 11 or more subjects with controlled disease are observed in 44 patients.

Conditions

• Advanced Biliary Tract Cancer

Interventions

Type	Name	Description
DRUG	TS-1	Intervention is administered to patients in this Arm.
DRUG	Gemcitabine	Intervention is administered to patients in this Arm.
DRUG	Nivolumab	Intervention is administered to patients in this Arm.

Timeline

• Start date: 2019-12-27
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2019-11-21
• Last updated: 2025-07-22

Locations

6 sites across 1 country: Taiwan