Comparison Percutaneous Cryosurgery and Irreversible Electroportion in Unresectable Liver Cancer Close to Diaphragmatic Dome
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
- Evaluate the safety of IRE for unresectable liver cancer close to diaphragmatic dome using Common terminology Criteria for Adverse Events (CTCAE).
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of irreversible electroportion in unresectable liver cancer close to diaphragmatic dome.
详细描述
Single-arm pilot clinical trial. Patients will be subjected to irreversible electroporation (IRE) as the sole treatment of liver cancer close to diaphragmatic dome.
This pilot study was designed to study the feasibility and safety of treatment as an alternative therapeutic IRE in the treatment of neoplastic nodules in the liver, with particular reference to close to diaphragmatic dome, where the current therapeutic arsenal is inadequate or counter-indicated.
To perform the IRE procedure the IRE NanoKnife™ System (AngioDynamics) will be used.
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
- •Liver cancer diagnosed by positive biopsy or non-invasive criteria,
- •Tumors from diaphragm is <1 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 ≤ 5 cm in diameter,
- •Child-Pugh class A,B
- •Eastern Cooperative Oncology Group (ECOG) score of 0-1,
- •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
- •liver cancer 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
Evaluate the safety of IRE for unresectable liver cancer close to diaphragmatic dome using Common terminology Criteria for Adverse Events (CTCAE).
时间窗: up to 7 days
Safety using Common terminology Criteria for Adverse Events (CTCAE).
次要结局
- Evaluate the efficacy of IRE for unresectable liver cancer close to diaphragmatic as measured by cell death of CRLM after IRE is demonstrated macroscopically by using vitality-staining with triphenyl-tetrazoliumchloride (TTC)(1 year)