drugset / Trial / NCT02425137
A Study of S-1 in Combination With Gemcitabine as First-Line Treatment in Patients With Advanced Biliary Tract Cancer
Phase 2
Completed
51 enrolled
TTY Biopharm
Chang Gung Memorial Hospital · collabNational Cheng-Kung University Hospital · collabNational Taiwan University Hospital · collabTaipei Veterans General Hospital, Taiwan · collab
NaSingle-groupOpen-labelTreatment
Summary
Primary Objective: To evaluate disease control rate (DCR) of S-1 in combination with gemcitabine in patients with advanced biliary tract cancer Secondary Objectives: * To evaluate overall response rate (ORR) * To evaluate progression-free survival (PFS) * To evaluate overall survival (OS) * To assess the safety profile
Timeline
- Start
- 2015-04
- Primary completion
- 2017-05
- Completion
- 2017-05
Outcome
Met primary endpoint
paper The study met its primary endpoint with a 12-week DCR of 69.6% in 46 evaluable patients. PMID 32463975 ↗
Publications
- Results Morizane C, Okusaka T, Mizusawa J, Takashima A, Ueno M, Ikeda M, Hamamoto Y, Ishii H, Boku N, Furuse J. Randomized phase II study of gemcitabine plus S-1 versus S-1 in advanced biliary tract cancer: a Japan Clinical Oncology Group trial (JCOG 0805). Cancer Sci. 2013 Sep;104(9):1211-6. doi: 10.1111/cas.12218. Epub 2013 Jul 25.
- Chiang NJ, Chen MH, Yang SH, Hsu C, Yen CJ, Tsou HH, Su YY, Chen JS, Shan YS, Chen LT. Multicentre, phase II study of gemcitabine and S-1 in patients with advanced biliary tract cancer: TG1308 study. Liver Int. 2020 Oct;40(10):2535-2543. doi: 10.1111/liv.14538. Epub 2020 Jun 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gemcitabine | Small molecule | 800 mg/m2 | — |
| Subject | S-1 | Small molecule | 80 mg | Oral |
| Subject | S-1 | Small molecule | 100 mg | Oral |
| Subject | S-1 | Small molecule | 120 mg | Oral |