Hepatocellular Carcinoma
Conditions
Keywords
Hepatocellular carcinoma, immunotherapy, alpha foetoprotein, dendritic cells
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.
Interventions
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
Sponsors
Nantes University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 3 days after each injection | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analysis of T lymphocytes | before each injection | The secondary aim of the study is to evaluate the anti-AFP immunizing response among patients who received the treatment |
Countries
France
Outcome results
None listed