Postoperative adjuvant immunotherapy of tumor specific peptide vaccine for esophageal cancer patients with pathological lymph node metastasis who underwent preoperative therapy followed by surgery- single institute exploratory Phase II trial
Phase 2
- Conditions
- esophageal cancer
- Registration Number
- JPRN-UMIN000003557
- Lead Sponsor
- Kindai University Faculty of Medicine, Department of Surgery
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
1)Infectious disease (ex. patients with high fever of 38.5 degrees C or more, et cetra) 2)Severe heart disease or past history of the disease 3)Severe postoperative complications (ileus, interstitial pneumonia, uncontrolled DM, renal failure, cirrhosis, et cetra) 4)Severe mental disorder 5)Another active malignant disease 6)Brestfeeding and pregnancy (woman of child bearing potential) 7)Man with an intention to get with child 8)Autoimmune disease 9)Retention of pericardial fluid to cause heart failure or pericarditis 10)Decision of unsuitableness by principal investigator or physician-in-charge
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relapse free Survival
- Secondary Outcome Measures
Name Time Method Esophageal cancer specific survival Overall survival Adverse event Feasibility immunological response Expression of tumor specific antigen Expression of HLA calss I Expression of CD(+ T cell and PDL1