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The goal of this clinical trial is to evaluate the safety and efficacy of anti-GPC3 scFv-41BB-CD3ζ-tEGFR chimeric antigen receptor (CAR)-modified T (CAR-T) cells in treating patients with GPC3-positive advanced hepatocellular carcinoma (HCC).
Primary Objectives:
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anti-GPC3 CAR-T | Experimental | Transcatheter arterial chemoembolization (TACE) combine with GPC3-CART infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retroviral vector-transduced autologous T cells to express anti-GPC3 CARs | Biological | transcatheter arterial chemoembolization + CAR-T infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0 | Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0 | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Overall complete remission rate defined by the standard response criteria | Overall complete remission rate defined by the standard response criteria | 8 weeks |
| Persistence: Duration of CAR-positive T cells in circulation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oncology, Xinqiao Hospital | Chongqing | Chongqing Municipality | 400037 | China |
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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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| ID | Term |
|---|---|
| C024352 | fludarabine |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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| Fludarabine | Drug | Fludarabine will be administered at dose of 25mg/m2/d |
|
| Cyclophosphamide | Drug | Cyclophosphamide will be administered at dose of 40mg/kg for 1 day and then fludarabine will be given for the next 5 days and then the T cells will be administered |
|
Duration of CAR-positive T cells in circulation
| 6 months |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |