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This is a Phase I, open-label, multi-center study to assess the safety, pharmacokinetics, and preliminary efficacy of GPC3-directed chimeric antigen receptor modified T cells injection (Ori-C101) in Advanced Hepatocellular Carcinoma(HCC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ori-C101 ( GPC3-directed chimeric antigen receptor modified T cells ) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ori-C101 | Biological | Hepatic arterial infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose of Ori-C101 | The MTD is defined as the highest dose with an observed incidence of DLT in no more than one out of six patients treated at a particular dose level. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Objective response is defined as the participants with a partial response (PR) or better by the RECIST1.1 criteria. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 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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| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | China |
|
| The first hospital of Jilin University | Recruiting | Changchun | Jilin | China |
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| West China Hospital | Recruiting | Chengdu | Sichuan | China |
|
| Sir Run Run Shaw Hospital | Recruiting | Hangzhou | Zhejiang | China |
|
| Lishui Central Hospital | Recruiting | Lishui | Zhejiang | China |
|
| Zhongshan Hospital Fudan University | Recruiting | Shanghai | China |
|
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |