NCT02425059已完成不适用
Irreversible Electroporation(IRE) For Unresectable Rectal Neoplasms: 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 30 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
- 30
- 试验地点
- 1
- 主要终点
- Number of participants with Adverse events
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 Rectal Neoplasms.
详细描述
By enrolling patients with unresectable Rectal Neoplasms adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous IRE for unresectable Rectal Neoplasms.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rectal Neoplasms diagnosed by positive biopsy or non-invasive criteria,
- •Not suitable for surgical resection,
- •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
Number of participants with Adverse events
时间窗: 6 month
次要结局
- Percentage of lesions that show no sign of recurrence 12 months after IRE(12 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Irreversible Electroporation(IRE) For Unresectable Portal Venous Tumor EmboliLiver CancerNCT02333773Fuda Cancer Hospital, Guangzhou15
已完成
不适用
Irreversible Electroporation(IRE) For Unresectable Esophageal NeoplasmsEsophageal NeoplasmsNCT02430701Fuda Cancer Hospital, Guangzhou30
已完成
不适用
Irreversible Electroporation(IRE) For Unresectable Laryngeal NeoplasmsLaryngeal NeoplasmsNCT02430675Fuda Cancer Hospital, Guangzhou30
已完成
不适用
Irreversible Electroporation(IRE) For Unresectable Lymph Node Metastases(Close to Nerve)Lymph Node MetastasesNCT02430766Fuda Cancer Hospital, Guangzhou30
已完成
不适用
Irreversible Electroporation(IRE) For Unresectable Urinary Bladder NeoplasmsUrinary Bladder NeoplasmsNCT02430623Fuda Cancer Hospital, Guangzhou30