Studio Clinico Pilota Con Uso di Elettroporazione Irreversibile (IRE) Nel Trattamento di Lesioni Neoplastiche Epatiche Con Localizzazione ad accessibilità Limitata o ad Alto Rischio
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Effectiveness of IRE for the treatment of metastatic liver cancer or cholangiocarcinoma.
研究概览
简要总结
Single-arm pilot clinical trial. Patients will be subjected to irreversible electroporation (IRE) as the sole treatment of nodules not considered treatable by resection or thermal ablation.
详细描述
Single-arm pilot clinical trial. Patients will be subjected to irreversible electroporation (IRE) as the sole treatment of nodules not considered treatable by resection or thermal ablation.
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 metastatic liver cancer and cholangiocarcinoma, 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
- 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
- •older than 18 years,
- •male or female,
- •diagnosis of secondary liver cancer or cholangiocarcinoma based on positive biopsy or noninvasive criteria,
- •presence of at least one lesion untreatable by surgical resection or ablation for microwave or radio frequency,
- •the target nodule must have a diameter of ≤ 5 cm
- •ECOG score(Eastern Cooperative Oncology Group) 0,
- •ASA score (American Society of Anesthesiologists) ≤ 3,
- •prothrombin time ratio >50%
- •platelet count >50x10^9/l,
- •patient's ability to discontinue anticoagulant and antiplatelet therapy for seven days before and seven days after surgery with NanoKnife™,
- •ability to understand and willingness to sign the written informed consent form (ICF),
- •life expectancy of at least 3 months.
排除标准
- •presence of more than 5 liver lesions,
- •previous treatment of the target nodule,
- •patient received systemic chemotherapy within 30 days of treatment with the IRE NanoKnife™,
- •heart failure, coronary artery disease or arrhythmia in progress, active implantable devices (eg pacemaker),
- •pregnant women or women of childbearing potential not using an acceptable method of contraception,
- •patient undergoing treatment with an investigational drug within 30 days of treatment with the IRE NanoKnife™,
- •in the opinion of the researcher, anyone who can not follow the calendar of visits and assessments of the Protocol.
结局指标
主要结局
Effectiveness of IRE for the treatment of metastatic liver cancer or cholangiocarcinoma.
时间窗: 1 month post-intervention
The primary measurement parameter for the purposes of this determination is the evaluation of the response of IRE treated lesions according to modified RECIST criteria using CT images or magnetic resonance imaging performed 20 to 40 days after treatment.
次要结局
- Safety(30 days post-intervention)
- Time to in situ recurrence(2 years post-intervention)
研究者
Prof. Umberto Cillo
Director of the Hepatobiliary Surgery and Liver Transplantation Unit
Azienda Ospedaliera di Padova