Immunotherapy of Hepatocellular Carcinoma by Induction of Anti-alpha Fetoprotein Response

Nantes University Hospital (NUH)

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: injection of the cell therapy product

Study type: Interventional

Funder types: Other

Identifiers

NCT01128803

06/9-P

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)