Multicenter phase II study of second-line S-1 monotherapy in patients with gemcitabine-refractory advanced biliary tract cancer
Phase 2
- Conditions
- Gemcitabine-refractory advanced biliary tract cancer
- Registration Number
- JPRN-UMIN000001614
- Lead Sponsor
- Faculty of Medicine, University of Tokyo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 22
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients with an active concomitant infection 2) Patients with digestive ulcer or gastrointestinal bleeding 3) Patients with severe cardiovascular or renal disease 4) Patients with uncontrollable massive pleural effusion or massive ascites 5) Patients with an active concomitant malignancy 6) Pregnant, lactating female and patients of reproductive potential who did not use effective contraception 7) Patients with a previous history of a severe drug hypersensitivity 8) Patients receiving anti-cancer drugs 9) Inappropriate patients for entry on this study in the judgement of the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method response rate
- Secondary Outcome Measures
Name Time Method Time to progression, Overall survival, Toxicity