Phase 1/2 trial of oral S-1 plus hepatic intra-arterial Gemcitabine in unresectable biliary cancer
Phase 1
- Conditions
- nresectable Biliary cancer
- Registration Number
- JPRN-UMIN000003803
- Lead Sponsor
- Department of 4th Internal medicine,Sapporo Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 28
Inclusion Criteria
Not provided
Exclusion Criteria
1. Patienta with a medical history of severe hypersensitivity . 2. With severe allergy for GEM or TS-1. 3. Patients under treatment with flucytosine, phenytoin or warfarin potassium . 4. With steroid. 5. Active infection 6. Severe diarrhea. 7. Active double cancer. 8,9. Patients who are pregnant,lactating or are suspected to be a pregnant 10. With hepatomesenteric-type Variation of Hepatic artery. 11. With pulmonary fibrosis 12,13. With severe heart disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase1 safty Phase2 anti-tumor effect(response rate)
- Secondary Outcome Measures
Name Time Method Progression-free survival Overall survival Drug administration compliance