PhaseI/II study of WT1 peptide vaccination plus gemcitabine and cisplatin versus gemcitabine and cisplatin in advanced biliary tract cancer
Phase 1
- Conditions
- advanced biliary tract cancer
- Registration Number
- JPRN-UMIN000004886
- Lead Sponsor
- ational Cancer Center Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 106
Inclusion Criteria
Not provided
Exclusion Criteria
1) Simultaneous or metachronous (within 5 years) double cancers, with the exception of intramucosal tumor curable with local therapy 2) Pregnant or lactating women or women of childbearing potential and men who want to get partner pregnant 3) Psychosis 4) Patients requiring systemic steroids medication 5) Interstitial pneumonia or fibroid lung 6) Active bacterial or fungous infection 7) Severe complication 8) Patients who can' t receive neither iodic drug nor gadolinium because of drug allergy 9) Inadequate physical condition, as diagnosed by primary physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1-year survival
- Secondary Outcome Measures
Name Time Method progression-free survival, response rate, overall survival, 2-year survival, adverse events, severe adverse events, vaccination biomarker