Study of the Combined Therapy of Irreversible Electroporation（IRE） and Nature Killer (NK) Cells for Advanced Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Relief degree
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of the combined therapy using irreversible electroporation（IRE）and nature killer(NK) cells for advanced pancreatic cancer.
详细描述
By enrolling patients with pancreatic 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 irreversible electroporation（IRE）and nature killer（NK） cells for advanced pancreatic cancer.
The efficacy will be evaluated according to relief degree,progress free survival(PFS) and overall survival(OS).
The safety will be evaluated by statistics of adverse reaction
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis：advanced and active pancreatic cancer
- •The tumour is measurable
- •Eastern Cooperative Oncology Group(ECOG) score：0~2；3 but has no relationship with tumour
- •Vital organ function is normal:
- •total bilirubin(TB) <68μmol/L aspartate aminotransferase(AST)<90 IU/L Cre<353μmol/L white blood cell count(WBC)<9×10^9/L,when WBC is close to or even greater than 9×10^9/L，the recommended dose should be halved platelet count(PLT)>80×10^9/L Red blood cell specific volume(HCT)>0.20 Non severe viral or bacterial infection
- •Non pregnant and lactating patients
- •Non allergic reactions to biological products
- •Informed and consent
排除标准
- •Patients with cardiac pacemaker
- •Patients with severe cardiac and pulmonary dysfunction
- •Patients that the researchers do not think fit into the group,including patients failed in compliance assessment
研究组 & 干预措施
IRE & NK cells
Advanced pancreatic cancer patients received both irreversible electroporation (IRE ) and immunotherapy of nature killer(NK) cells
干预措施: NK cells (Biological)
irreversible electroporation (IRE)
Advanced pancreatic cancer patients received only irreversible electroporation (IRE) without immunotherapy
干预措施: irreversible electroporation (IRE ) (Procedure)
IRE & NK cells
Advanced pancreatic cancer patients received both irreversible electroporation (IRE ) and immunotherapy of nature killer(NK) cells
干预措施: irreversible electroporation (IRE ) (Procedure)
结局指标
主要结局
Relief degree
时间窗: 1 year
It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）
次要结局
- Overall survival（OS）(3 year)
- Progress free survival（PFS）(1 year)