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.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Advanced Hepatocellular Carcinoma
- Sponsor
- Central South University
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Incidence of Adverse Events
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Wei Wang,MD
Principal for The Institute for Cell Transplantation and Gene Therapy
Central South University
Eligibility Criteria
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;
Outcomes
Primary Outcomes
Incidence of Adverse Events
Time Frame: up to 2 years
Number of participants with Adverse Events using Common Terminology Criteria for Adverse Events (CTCAE v4.03) in patients.
Secondary Outcomes
- Progression Free Survival(up to 2 years)
- Overall Survival(up to 2 years)
- Time to First Response(up to 2 years)
- Response Rate(up to 12 months)
- Duration of Response(up to 2 years)