Phase I/II study of gemcitabine/cisplatin/S-1(GCS) combination therapy for patients with advanced biliary tract cancer
Phase 1
- Conditions
- Patients with advanced biliary tract cancer that was not amenable to potentially curative surgery or that had recurred after surgery
- Registration Number
- JPRN-UMIN000004468
- Lead Sponsor
- Kansai Hepatobiliary Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 55
Inclusion Criteria
Not provided
Exclusion Criteria
1. Patients with interstitial pneumonia or pulmonary fibrosis 2. Patients with uncontrollable diabetes mellitus, liver disease, angina pectoris or a new onset of myocardial infarction within 3 months 3. Patients with severe active infection 4. Patients who are pregnant or lactating, or have an intention to get pregnant 5. Patients with a history of severe drug allergy 6. Patients with other serious comorbid disease 7. Patients with mental disease 8. Patients who are judged inappropriate for the entry into the study by the principle doctor 9. Patients with watery diarrhea
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I Safety Phase II Overall Survival
- Secondary Outcome Measures
Name Time Method Phase II Toxicity and response rate