Phase I study of Gemcitabine, Cisplatin and S-1 for advanced biliary tract cancer.
Phase 1
- Conditions
- Biliary tract cancer
- Registration Number
- JPRN-UMIN000006123
- Lead Sponsor
- Tsukuba University Hospital, Division of Gastroenterology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
Not provided
Exclusion Criteria
1.With a history of severe drug allergy 2.Active infection 3.Sever complication 4.With uncontrollable diabetes mellitus (HbA1C >=8.0%) 5.With steroid 6.With interstitial pneumonia or pulmonary fibrosis 7.With severe pleural effusion or ascites 8.Active double cancer 9.Patients who are pregnant or lactating, or have an intention to get pregnant 10.Inadequate physical condition, as diagnosed by primary physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Recommended dose
- Secondary Outcome Measures
Name Time Method Dose-limiting toxicity, maximum tolerated dose, toxicity, relative dose intensity, tumor response, progression-free survival, and overall survival