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

  • STATUS
    Recruiting
  • participants needed
    10
  • sponsor
    Central South University
Updated on 19 February 2024

Summary

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.

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.

Details
Condition Advanced Hepatocellular Carcinoma
Age 18years - 70years
Treatment Transcatheter arterial chemoembolization, PD-1 knockout engineered T cells
Clinical Study IdentifierNCT04417764
SponsorCentral South University
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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