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

Phase 2TerminatedNCT01128803

Nantes University Hospital1 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatocellular Carcinoma

Interventions

injection of the cell therapy productPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (4)

University Hospital of Angers

Angers, France

CHD La Roche-sur-Yon

La Roche-sur-Yon, France

Nantes University Hospital

Nantes, France

CH Saint Nazaire

Saint-Nazaire, France

Outcomes

Primary Outcomes

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.

Time frame: 3 days after each injection

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Time frame: 3 weeks after the last injection

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Time frame: 3 months after the last injection

Secondary Outcomes

Analysis of T lymphocytes

The secondary aim of the study is to evaluate the anti-AFP immunizing response among patients who received the treatment

Time frame: before each injection

Analysis of T lymphocytes

Time frame: 3 weeks after the last injection

Analysis of T lymphocytes

Time frame: 3 months after the last injection

Data from ClinicalTrials.gov

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