A randomized phase II trial of adjuvant immunotherapy with alpha-GalactosylCeramide-pulsed dendritic cells for advanced oropharyngeal and hypopharyngeal cancer following standard therapy
Phase 2
Recruiting
- Conditions
- Oropharyngeal and Hypopharyngeal squamous cell carcinoma
- Registration Number
- JPRN-UMIN000007559
- Lead Sponsor
- Department of Otorhinolaryngology, Head and Neck Surgery, Graduate School of Medicine, Chiba University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
Not provided
Exclusion Criteria
Patients who have: uncontrolled diabetes mellitus, pulmonary fibrosis, and/or infection; a history of hepatitis; a positive response for hepatitis B surface antigen, or human immunodeficiency virus (HIV), hepatitis C virus, or human T-lymphotrophic virus antibodies; serious cardiac disease; recieived concurrent corticosteroid therapy; pregnancy or lactation; autoimmune diseases; been judged to be inappropriate to participate in this study by principle investigator or co-investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relapse-free survival
- Secondary Outcome Measures
Name Time Method Two-year relapse rate Overall survival rate Specific immune responses of peripheral blood Frequency and seriousness of adverse events