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This study will evaluate the safety and effect of transcatheter arterial chemoembolization (TACE)combined with percutaneous transhepatic PD-1 knockout engineered T cell infusion in the Paitents with advanced hepatocellular carcinoma(HCC). Blood and tissue samples will also be collected for research purposes.
This is a clinical study to investigate the safety and effect of transcatheter arterial chemoembolization (TACE) in combination with PD-1 knockout engineered T cells in the Paitents with advanced hepatocellular carcinoma. TACE would block the blood supply of the tumor to achieve ischemic, hypoxic andnecrotic effects. The PD-1 knockout engineered T cells were also prepared from autologous origin using CRISPR Cas9 technology. The patients performed one TACE treatment followed by 3 cycles of PD-1 edited T cells by percutaneous infusion in the peripheral of tumor under the guide of CT every four weeks. The safety and clinical efficacy will be evaluated. biomarkers and immunological markers will be monitored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TACE combined PD-1 knockout T cell treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcatheter arterial chemoembolization | Procedure | The patients are plan to operated by Transcatheter arterial chemoembolization(TACE). |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | Number of participants with Adverse Events using Common Terminology Criteria for Adverse Events (CTCAE v4.03) in patients. | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate | To evaluate the objective response rate (ORR) ,refers to the proportion of patients whose tumors shrink to a certain extent and remain unchanged for a certain period of time, including patients with CR+PR.Tumors are assessed at baseline, the 8th week, the 16th week,the 24th week, and once every 12 weeks during the treatment and follow-up period per RECIST1.1. | up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Wang, MD | Contact | 86-0731-88618411 | cjr.wangwei@vip.163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The 3rd Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | 410013 | China |
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| PD-1 knockout engineered T cells | Biological | The PD-1 knockout engineered T cells are prepared from autologous origin using CRISPR Cas9 technology. The patients are plan to receive 3 or more cycles of PD-1 knockout engineered T cells infusion by percutaneous fine needle liver puncture with a 4-weeks interval. A total of 1 to 3× 10^9 PD-1 edited T cells will be infused each cycle. Patients continued receiving treatment unless they had unacceptable adverse effects, or progressive disease confirmed by CT or they withdrew consent. |
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| Time to First Response | To evaluate time to first response, defined as the time from the first cell infusion to the first observed complete response (CR) or partial response (PR). | up to 2 years |
| Duration of Response | To evaluate the duration of response (DOR), defined as the time from the first observed CR or PR to the first observed PD or death from any cause. | up to 2 years |
| Progression Free Survival | To evaluate the progression free survival (PFS), defined as the time from the first cell infusion to the first observed PD or death from any cause. | up to 2 years |
| Overall Survival | To evaluate the overall survival (OS), defined as the time from the first cell infusion to death. | up to 2 years |