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| ID | Type | Description | Link |
|---|---|---|---|
| CIC 0203/074 | |||
| LOC 06/07 |
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| Name | Class |
|---|---|
| Innate Pharma | INDUSTRY |
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For most patients with hepatocellular carcinoma, surgery or other curative procedures are not possible and only palliative measures could be applied (chemoembolization, targeted drugs, best supportive cares, etc). In the ICAR study, increasing doses of a cell therapy product will be evaluated in patients in a palliative setting. All patients will have one hepatic intra-arterial injection of immunological cells (gamma-delta T lymphocytes) and will be evaluated for safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Single hepatic intra arterial administration of 500 millions T gamma delta lymphocytes |
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| 2 | Experimental | Single hepatic intra arterial administration of 1000 millions T gamma delta lymphocytes |
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| 3 | Experimental | Single hepatic intra arterial administration of 2000 millions T gamma delta lymphocytes |
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| 4 | Experimental | Single hepatic intra arterial administration of 4000 millions T gamma delta lymphocytes |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T gamma delta lymphocytes | Other | Single hepatic intra arterial administration of increasing doses of T gamma delta lymphocytes |
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| Measure | Description | Time Frame |
|---|---|---|
| Onset of: thrombosis of hepatic artery, grade 4 liver toxicity, or grade 3 or more allergic, neurological, dermatological, infectious, or respiratory reaction | Within 14 days after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Onset of clinical, biological signs or images evocative of lymphocyte-induced tumor cytotoxicity and/or of a persistence of gamma-delta T cells in peripheral blood. Tumor response will be evaluated with the RECIST criteria. | 3 months |
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Inclusion Criteria:
Non inclusion Criteria:
Exclusion Criterion:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Luc RAOUL, MD, PhD | CRLCC Eugène Marquis, Rennes | Principal Investigator |
| Eric BELLISSANT, MD, PhD | Rennes University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unité de Thérapie Cellulaire, Laboratoire de Cytogénétique et Biologie Cellulaire, CHU Rennes | Rennes | 35000 | France | |||
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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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| Département d'Oncologie Médicale - CRLCC Eugène Marquis |
| Rennes |
| 35042 |
| France |
| Service de Chirugie Viscérale - Hôpital de Pontchaillou | Rennes | France |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |