drugset

drugset / Trial / NCT04172402

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

NCT04172402 ↗

Phase 2 Completed 48 enrolled National Health Research Institutes, Taiwan Chang Gung Memorial Hospital · collab China Medical University Hospital · collab Kaohsiung Medical University Chung-Ho Memorial Hospital · collab National Cheng-Kung University Hospital · collab National Taiwan University Hospital · collab Taipei Veterans General Hospital, Taiwan · collab

NaSingle-groupOpen-labelTreatment

Summary

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

Timeline

Start: 2019-12-27
Primary completion: 2024-12-31
Completion: 2024-12-31

Publications

Chiang NJ, Tang CY, Bai LY, Chang PC, Chen WM, Kang ST, Chen SC, Chen MH, Hsieh JC. Circulating miRNAs as potentially predictive biomarkers for chemoimmunotherapy in advanced biliary tract cancer: a post-hoc analysis of the phase II T1219 study. NPJ Precis Oncol. 2025 Aug 30;9(1):307. doi: 10.1038/s41698-025-01099-x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nivolumab	Monoclonal antibody	240 mg	—
Background	Gemcitabine	Small molecule	800 mg/m2	—
Background	S-1	Small molecule	80 mg	Oral
Background	S-1	Small molecule	100 mg	Oral
Background	S-1	Small molecule	120 mg	Oral

Indications