A randomized multicenter trial of adjuvant IMF-001 after curative resection for esophageal cancer with NY-ESO-1 antigen (phase II study)
Not Applicable
- Conditions
- Patients after curative resection for esophageal cancer with NY-ESO-1 antigen expression
- Registration Number
- JPRN-UMIN000007905
- Lead Sponsor
- Department of Immuno-gene Therapy, Mie University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients undergoing treatment with radiotherapy for esophageal cancer. 2) Patients with double cancer. 3) Patients with autoimmune disease. 4) HIV antibody positive. 5) History of serious anaphylaxis. 6) Within 4 weeks after treatment with immune suppressant, immune enhancer or systemically administered adrenocorticosteroid. 7) Pregnant or breast-feeding females and females who have a possibility of pregnancy. 8) Patients who are administered the other investigational product within 12 weeks of the secondary entry. 9) Any other inadequacy for this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease-free survival Safety
- Secondary Outcome Measures
Name Time Method Overall survival