Phase II study of gemcitabine, S-1, leucovorin combination therapy for advanced biliary tract cancer
Phase 2
- Conditions
- nresectable or recurrent biliary tract cancer
- Registration Number
- JPRN-UMIN000010678
- Lead Sponsor
- The University of Tokyo Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 45
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients with a previous history of a severe drug hypersensitivity 2) Patients with an active concomitant infection 3) Patients with severe comobidities (cardiovascular disease, renal failure, hepatic failure, digestive ulcer, and gastrointestinal bleeding). 4) Patients with an active pulmonary fibrosis or interstitial pneumonia 5) Patients with severe diahrrea 6) Pregnant, lactating female and patients of reproductive potential who did not use effective contraception 7) Patients with uncontrollable massive pleural effusion or massive ascites 8) Patients with an active concomitant malignancy 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 Progression-free survival
- Secondary Outcome Measures
Name Time Method Overall survival, response rate, adverse events