Combination of Irreversible Electroporation and NK Immunotherapy for Recurrent Liver Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Relief degree of tumors
研究概览
简要总结
The aim of this study is the safety and efficacy of irreversible electroporation (IRE) plus natural killer (NK) immunotherapy to recurrent liver cancer.
详细描述
By enrolling patients with recurrent liver cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using IRE and NK cells.
The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
- •Body tumor 1-6, the maximum tumor length < 5 cm
- •KPS ≥ 70, lifespan > 6 months
- •Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L
排除标准
- •Patients with cardiac pacemaker
- •Patients with brain metastasis
- •Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
研究组 & 干预措施
Electroporation
In this group, the patients will receive regular irreversible electroporation (IRE) treatment to control the tumor growth. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
干预措施: Irreversible Electroporation (Device)
Electroporation and natural killer
In this group, the patients will receive regular irreversible electroporation (IRE) treatment in combination with multiple natural killer (NK) immunotherapies. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
干预措施: Irreversible Electroporation (Device)
Electroporation and natural killer
In this group, the patients will receive regular irreversible electroporation (IRE) treatment in combination with multiple natural killer (NK) immunotherapies. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
干预措施: Natural killer (Biological)
结局指标
主要结局
Relief degree of tumors
时间窗: 3 months
It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）
次要结局
- Progress free survival（PFS）(1 year)
- Overall survival（OS）(3 year)