WT1 peptide-based cancer vaccine combined with gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: a randomised, multicenter, phase 2 clinical study
Phase 2
- Conditions
- Pancreatic cancer
- Registration Number
- JPRN-UMIN000005248
- Lead Sponsor
- Department of Cancer Immunotherapy, Osaka university Graduate school of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
Not provided
Exclusion Criteria
1) Simultaneous or metachronous (within 5 years) double cancers, with exception of intramucosal tumor curable with local therapy 2) Pregnant or lactating women or women fo childearing potential, and men who want to get partner pregnat 3) Psychosis 4) Patients requiring systemic immunosuppresive agents, or moderate or higher dose of steroid with exception of usage for cancer pain 5) Pulmonary fibrosis or interstitial pneumonitis 6) Active bacterial or fungal infection 7) Severe complications 8) MDS, MDS/MPD, MPD 9) Severe drug allergy 10) Inadequate physical condition, as diagnosed by the primary physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1-year overall survival rate
- Secondary Outcome Measures
Name Time Method Overall Survival(OS), 6-month OS rate, 1.5-year OS rate, Progression Free Survival, Disease control rate, Clinical benefit response, QOL, toxic effects, immunological monitoring, and non-immunological monitorings