NCT02333773已完成不适用
Irreversible Electroporation(IRE) For Unresectable Portal Venous Tumor Emboli: Phase I and Phase II Clinical Trial
Fuda Cancer Hospital, Guangzhou1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2015年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Safety (adverse effects)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Portal venous tumor emboli.
详细描述
By enrolling patients with unresectable Portal venous tumor emboli adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous or intraoperative IRE for unresectable Portal venous tumor emboli.
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
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Liver cancer diagnosed by positive biopsy or non-invasive criteria,
- •Liver cancer with Portal venous tumor emboli,
- •Not suitable for surgical resection or transplantation,
- •Child-Pugh class A,B
- •Eastern Cooperative Oncology Group (ECOG) score of 0-1,
- •A prothrombin time ratio > 50%,
- •Platelet count > 80x10^9/L,
- •Ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,
- •Able to comprehend and willing to sign the written informed consent form (ICF),
- •Have a life expectancy of at least 3 months.
排除标准
- •Cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
- •Any active implanted device (eg Pacemaker),
- •Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
- •Have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System,
- •Are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.
结局指标
主要结局
Safety (adverse effects)
时间窗: 6 month
adverse effects
次要结局
- Progress free disease (PFS)(12 months)
- Efficacy (percentage of lesions that show no sign of recurrence 12 months after IRE)(12 months)
- Voltage (A minimum and maximum range of voltage for safe and effective IRE)(3 months)
- Overall survival (OS)(36 months)
研究者
研究点 (1)
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