A Prospective Clinical Trial Using Irreversible Electroporation (IRE) for the Treatment of Unresectable Hepatic Carcinoma Close to the Gallbladder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 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 investigate the safety and efficacy of irreversible electroporation for unresectable Hepatic carcinoma close to the gallbladder, also Progress Free Survival (PFS) will be recorded.
详细描述
Hepatic carcinoma is the fifth most common cancer worldwide and a large proportion of patients are unsuitable for tumor resection because of factors such as poor hepatic reserve(cirrhosis), multicentric tumors or near vital structures such as vessels, diaphragmatic dome and gallbladder. Direct ablative treatments include radiofrequency ablation, microwave (MW) ablation and cryotherapy and irreversible electroporation had been used successful as a therapeutic choice for unresectable patients. At the same time，Irreversible electroporation(IRE)，which was applied with a novel ablation technology, can induce tissue necrosis by utilizing short pulses of high-voltage electrical energy. The technique also had many advantages, including Short ablation time, preservation of vital structures within IRE-ablated zone, avoidance of heat/cold-sink effect, complete ablation with well-demarcated margin and real-time monitoring of IRE ablation.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hepatic carcinoma diagnosed by positive biopsy or non-invasive criteria,
- •Tumor from gallbladder is <0.5 cm
- •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 ≤ 7 cm in diameter,
- •Child-Pugh class A,B
- •Eastern Cooperative Oncology Group (ECOG) score of 0-1,
- •American Society of Anaesthesiologists (ASA) score ≤ 3,
- •a prothrombin time ratio > 50%,
- •platelet count > 80x109/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,
- •Hepatic carcinoma 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)