NCT01078415已完成不适用
A Prospective, Multi-Center, Clinical Trial Using Irreversible Electroporation (IRE) for the Treatment of Early-Stage Hepatocellular Carcinoma (HCC)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 12
- 主要终点
- Treatment efficacy as measured by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria by Computed Tomography (CT) or Magnetic Resonance (MR) imaging.
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of the NanoKnife LEDC System for the treatment of early-stage hepatocellular carcinoma (HCC).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HCC diagnosed by positive biopsy or non-invasive criteria,
- •not suitable for surgical resection or transplantation,
- •have at least one, but less than or equal to 3 tumors,
- •of the tumour(s) identified, each tumor must be ≤ 3 cm in diameter,
- •Child-Pugh class A,
- •Eastern Cooperative Oncology Group (ECOG) score of 0,
- •American Society of Anaesthesiologists (ASA) score ≤ 3,
- •a prothrombin time ratio > 50%,
- •platelet count > 50x109/L,
- •ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,
- •are 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
- •eligible for surgical treatment or transplantation for HCC,
- •presence of vascular invasion or extrahepatic metastases,
- •received previous treatment for HCC,
- •HCC developed on an already transplanted liver,
- •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
Treatment efficacy as measured by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria by Computed Tomography (CT) or Magnetic Resonance (MR) imaging.
时间窗: 30 days (+/- 3 days) post treatment
次要结局
- Safety using Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria.(Immediately post treatment to 2 years post treatment)
研究者
研究点 (12)
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