Status:
UNKNOWN
TACE Combined With PD-1 Knockout Engineered T Cell in Advanced Hepatocellular Carcinoma.
Lead Sponsor:
Central South University
Conditions:
Advanced Hepatocellular Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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 a...
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 hepa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04417764
Start Date
June 20 2019
End Date
December 31 2024
Last Update
February 9 2023
Active Locations (1)
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1
The 3rd Xiangya Hospital of Central South University
Changsha, Hunan, China, 410013