Randomized phase II study of gemcitabine and S-1 combination therapy versus gemcitabine in advanced biliary tract cancer (GS-COMBI).
Phase 2
- Conditions
- Advanced biliary tract cancer
- Registration Number
- JPRN-UMIN000001703
- Lead Sponsor
- Japanese Endoscopist & IVRists group for Biliary Tract Cancer (JEIBIC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 62
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients with an active concomitant infection 2) Patients with digestive ulcer or gastrointestinal bleeding 3) Patients with an active pulmonary fibrosis or interstitial pneumonia 4) Patients with an active concomitant malignancy 5) Pregnant, lactating female and patients of reproductive potential who did not use effective contraception 6) Patients with a previous history of a severe drug hypersensitivity 7) Patients receiving anti-cancer drugs 8) Patients with uncontrollable massive pleural effusion or massive ascites 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 Tumor response (Response rate, Disease control rate)
- Secondary Outcome Measures
Name Time Method progression-free survival, overall survival, adverse events