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The patients are plan to operated by Transcatheter arterial chemoembolization(TACE).

Transcatheter arterial chemoembolization

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.

PD-1 knockout engineered T cells

Wei Wang, MD

Xiaoqian Ma, MD

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.

TACE Combined With PD-1 Knockout Engineered T Cell in Advanced Hepatocellular Carcinoma.

Safety and Effect Assessment of TACE in Combination With Autologous PD-1 Knockout Engineered T Cells by Percutaneous Infusion in the Paitents With Advanced Hepatocellular Carcinoma.

Number of participants with Adverse Events using Common Terminology Criteria for Adverse Events (CTCAE v4.03) in patients.

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.

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).

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.

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.

To evaluate the overall survival (OS), defined as the time from the first cell infusion to death.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
TACE Combined With PD-1 Knockout Engineered T Cell in Advanced Hepatocellular Carcinoma.	NCT04417764	Advanced Hepato...	Transcatheter a... PD-1 knockout e...	18 Years - 70 Years	Central South University
TACE Combined With PD-1 Knockout Engineered T Cell in Advanced Hepatocellular Carcinoma.	NCT04417764	Advanced Hepato...	Transcatheter a... PD-1 knockout e...	18 Years - 70 Years	Central South University

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