Immunotherapy of Hepatocellular Carcinoma by Induction of Anti-alpha Fetoprotein Response
Phase 1
Terminated
- Conditions
- Hepatocellular Carcinoma
- Registration Number
- NCT01128803
- Lead Sponsor
- Nantes University Hospital
- Brief Summary
The secretion by tumor cells of alpha fetoprotein (AFP) was observed in 50 to 60% of hepatocellular carcinoma. The AFP can be used as a marker for tumor recurrence after treatment and may be considered as a tumor antigen specific for hepatocellular carcinoma.The aim of the project is to use the alpha fetoprotein (AFP) as a tumor antigen and to propose an approach of immunotherapy for hepatocellular carcinoma based on the injection of autologous dendritic cells loaded with specific peptides of AFP.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
Inclusion Criteria
- Negative test for pregnancy or effective contraception
- Patient HIV-, Hep B-, Hep C-, HTLV1 and 2-, Syphilis-
- HLA A 0201 group
Exclusion Criteria
- Life expectancy < 3 months
- Pregnancy or breast-feeding
- Severe auto-immune disease
- Another malignant tumor except if considered as cured since more than 5 years
- History of uncontrolled psychiatric condition
- Risk factors of Creutzfeldt Jacobs disease
- Decompensated cirrhosis(ascites or Child-Pugh score greater than 8)
- Hepatic transplantation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Number of Participants with Adverse Events as a Measure of Safety and Tolerability 3 months after the last injection
- Secondary Outcome Measures
Name Time Method Analysis of T lymphocytes 3 months after the last injection
Trial Locations
- Locations (4)
CHD La Roche-sur-Yon
🇫🇷La Roche-sur-Yon, France
CH Saint Nazaire
🇫🇷Saint Nazaire, France
Nantes University Hospital
🇫🇷Nantes, France
University Hospital of Angers
🇫🇷Angers, France