Trials / Completed
CompletedNCT02425137
A Study of S-1 in Combination With Gemcitabine as First-Line Treatment in Patients With Advanced Biliary Tract Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 51 (actual)
- Sponsor
- TTY Biopharm · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | S-1/Gemcitabine | Eligible patients will receive gemcitabine 800 mg/m2/day on day 1 and S-1 orally 80-120 mg/day (depending on patient's body surface area (BSA)) on day 1 to 10 in a 2-week cycle. |
Timeline
- Start date
- 2015-04-01
- Primary completion
- 2017-05-01
- Completion
- 2017-05-01
- First posted
- 2015-04-23
- Last updated
- 2019-08-21
Locations
4 sites across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT02425137. Inclusion in this directory is not an endorsement.