Phase I/II clinical trila by gemcitabine+CDDP- or S-1- combined peptide vaccination for metastatic biliary tract cancers
Not Applicable
- Conditions
- metastatic biliary tract cancers
- Registration Number
- JPRN-UMIN000004494
- Lead Sponsor
- Tohoku University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 22
Inclusion Criteria
Not provided
Exclusion Criteria
Patients -obtains previous radiation therapy for biliary tract cancers. -obtains brain metastasis not manipulated. -obtains active duplicated neoplastic diseases. -obtains co-morbidity as follows; intestinal paralysis, intestinal obstruction, diabetes mellitus, hypertension, angina pectoris, livet cirrhosis, pneumonitis, emphysema. -is HIV-positiveness -has past history of severe allergic reaction for gemcitabine, cisplatin, or TS-1. -obtains ascites or pleural effusion that needs treatment. -has severe diarrhea or GI bleeding. -has treatment by frucitosine -is pregnat or can be pregnant. -desires partners pregnancy. -has HLA-A genotype opened.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival
- Secondary Outcome Measures
Name Time Method DCR, RR, PFS, AE, immunological reactions (CTL, CD8, regT)