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

Study Overview
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Brief Summary
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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.

Official Title
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Phase I/II Multicenter: Immunotherapy of Hepatocellular Carcinoma by Induction of Anti-alpha Fetoprotein Response

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Procedure: injection of the cell therapy product


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: injection of the cell therapy product|Between D-15 and D-30: Cytapheresis D0: 1st injection of the cell therapy product D21: 2nd injection of the cell therapy product D42: 3rd injection of the cell therapy product and 1 injection of dendritic cells not loaded D45: cutaneous biopsies if induration > 2mm|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |  | 3 weeks after the last injection | 
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |  | 3 months after the last injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of T lymphocytes | The secondary aim of the study is to evaluate the anti-AFP immunizing response among patients who received the treatment | before each injection | 
| Analysis of T lymphocytes |  | 3 weeks after the last injection | 
| Analysis of T lymphocytes |  | 3 months after the last injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatocellular carcinoma, immunotherapy, alpha foetoprotein, dendritic cells