Phase I/II Multicenter: Immunotherapy of Hepatocellular Carcinoma by Induction of Anti-alpha Fetoprotein Response
Pre-inclusion Criteria :
- Adults (men or women) aged between 18 and 80 years
- Patients affiliated to a social security reimbursement system
- Signed informed consent
- Hepatocellular carcinoma
- At least one dosage with Alpha-foeto-protein ≥ 40 ng/ml
- Patient already treated with chemoembolization, percutaneous destruction (alcohol or
radiofrequency), surgery or Sorafenib.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
The main aim of this study is to test the absence of toxicity of the injection of autologist dendritic cells loaded with specific peptides of the AFP, for patients with hepatocellular carcinoma and already treated.
3 days after each injection
Jérôme GOURNAY, Dr
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)