Phase 1 clinical study on the combination therapy of CHP-NY-ESO-1 cancer vaccine and Poly-ICLC for the treatment of patients with NY-ESO-1 expressing refractory esophageal cancer
Phase 1
Recruiting
- Conditions
- Refractory esophageal cancer
- Registration Number
- JPRN-UMIN000007961
- Lead Sponsor
- Kyoto Prefectural University of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
Not provided
Exclusion Criteria
1. Past history of severe hypersensitivity 2. Positive for HIV antibody 3. Experience of autoimmune disease requiring treatment during 6 months preceding the day of consent 4. Use of steroids (more than 20 mg equivalent of prednisolone/day) or immunosuppressive drugs 5. Patients with following severe complications # severe heart disease or uncontrolled angina # Uncontrolled diabetes mellitus # Intestinal paresis or ileus # Active infections requiring antibiotics # Other severe complications 6. Pregnant or lactating women 7. Inappropriate for study entry judged by an attending physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maximum tolerated dose (MTD), dose limiting toxicity (DLT) and adverse effects.
- Secondary Outcome Measures
Name Time Method Immune response