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

Central South University

Status and phase: Enrolling; Phase 1

Conditions: Advanced Hepatocellular Carcinoma

Treatments: Procedure: Transcatheter arterial chemoembolization; Biological: PD-1 knockout engineered T cells

Study type: Interventional

Funder types: Other

Identifiers

NCT04417764

CellTransplant&GeneTherapy2020

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with unresectable hepatocellular carcinoma;
2. More than 18 years old;
3. Patients diagnosed with hepatocellular carcinoma by histopathology or imagings;
4. Liver function ChildPugh ≤7 points, Physical strength score ECOG-pts 0-1 points;
5. Maximum tumor diameter ≤10cm, tumor number ≤10, no vascular invasion or extrahepatic metastasis;
6. Other organs of the whole body function well;
7. Sign the informed consent;
8. Passed the review by the ethics committee.

Exclusion criteria

1. Less than 18 or more than 70 years old;
2. Lack of autonomous decision-making ability;
3. ECOG score >2, cachexia or multiple organ failure;
4. Metastases; The tumor was diffuse or metastasized widely and the expected survival time was less than 3 months.
5. Uncorrectable coagulation dysfunction with a history of bleeding; Organ transplant;
6. Patients with severe autoimmune diseases; Iodine contrast agent allergy; High allergic constitution;
7. The main portal vein was completely blocked by cancer embolism, with little collateral vascular formation;
8. Severe infection; AIDS, syphilis infection;
9. T cell lymphoma;
10. Patients with mental illness, severe trauma or other stress conditions;
11. Pregnant or nursing women;
12. Abnormal peripheral blood routine detection;
13. Failing to comply with the study protocol to complete the diagnosis and treatment project; Failed ethics committee review.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

TACE combined PD-1 knockout T cell treatment

Experimental group

Treatment:

Biological: PD-1 knockout engineered T cells

Procedure: Transcatheter arterial chemoembolization