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.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Incidence of Adverse Events
时间窗: up to 2 years
Number of participants with Adverse Events using Common Terminology Criteria for Adverse Events (CTCAE v4.03) in patients.
次要结局
- 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)
研究者
Wei Wang,MD
Principal for The Institute for Cell Transplantation and Gene Therapy
Central South University