Combination Therapy of Microwave Ablation and Expanding Activated Autologous Lymphocytes for Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Cumulative survival rates were calculated by the Kaplan-Meier method, and comparison between MWA and combination treatment will be done by the log-rank test.
研究概览
简要总结
The study is to observe safety, survival effect and peripheral T-lymphocyte subsets of combination therapy with percutaneous microwave ablation (MWA) and adoptive immunotherapy in hepatocellular carcinoma(HCC).
详细描述
Patients with HCC (tumor diameter ≤5 cm and fewer than three tumors) underwent radical MWA followed by cellular immunotherapy. In the CIK-based cohort, patients received 4-6 courses annually, starting at 2, 4, 6, 10, 14, and 18 weeks after MWA, followed by treatment every 12 weeks. Peripheral blood mononuclear cells were differentiated into phenotypically confirmed DCs and effector cells. DC-CIK and CTL were administered intraperitoneally, and CIK cells were infused intravenously.
In the NK-cell cohort, patients received six NK-cell infusions at 2-week intervals after complete MWA and normalization of body temperature. NK cells were expanded ex vivo from autologous peripheral blood, allogeneic peripheral blood, or umbilical cord blood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •single HCC of 5 cm or smaller;
- •three or fewer multiple HCC with a maximum dimension of 3 cm or less;
- •absence of portal vein thrombosis or extrahepatic metastases;
- •Child-Pugh classification A or B;
- •tumor accessible via a percutaneous approach. white blood cell count >2 x 109/L, platelet count >40 x 109/L,serum creatinine <110 μmol/L, aspartate aminotransferase <3 times the upper limit, serum bilirubin <2.5 times the upper limit, prothrombin time <19 seconds.
排除标准
- •pregnant or breast-feeding; psychiatric problems, addiction, or any other disorder that prevented informed consent;
- •active uncontrolled infection; concurrent systemic corticosteroid treatment;
- •systemic autoimmune disease;
- •clinically significant ischemic heart disease or cardiac failure;
- •and chemotherapy or radiotherapy within the preceding 6 months
研究组 & 干预措施
MWA only
The HCC patients will be treated only by MWA.No adoptive immunotherapy will be used.
干预措施: MWA (Procedure)
MWA combined with immunotherapy
The HCC patients will be treated firstly by MWA, and then treated by courses of adoptive immunotherapy.
干预措施: adoptive immunotherapy (Biological)
MWA combined with immunotherapy
The HCC patients will be treated firstly by MWA, and then treated by courses of adoptive immunotherapy.
干预措施: MWA (Procedure)
结局指标
主要结局
Cumulative survival rates were calculated by the Kaplan-Meier method, and comparison between MWA and combination treatment will be done by the log-rank test.
时间窗: up to 8 years
次要结局
- disease free survival rates were calculated by the Kaplan-Meier method, and comparison between MWA and combination treatment will be done by the log-rank test(up to 8 years)
研究者
Ping Liang
Professor
Chinese PLA General Hospital