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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| injection of the cell therapy product | Procedure | 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 |
| 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 |
| 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 |
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Pre-inclusion Criteria :
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jérôme GOURNAY, Dr | Nantes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Angers | Angers | 49000 | France | |||
| CHD La Roche-sur-Yon |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| 3 weeks after the last injection |
| Analysis of T lymphocytes | 3 months after the last injection |
| La Roche-sur-Yon |
| 85000 |
| France |
| Nantes University Hospital | Nantes | France |
| CH Saint Nazaire | Saint-Nazaire | 44000 | France |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |