NCT04760327招募中2 期
Electrochemotherapy of Gynecological Cancers
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Effectiveness of electrochemotherapy according to RECIST 1.1 criteria.
研究概览
简要总结
To determine the effectiveness, feasibility and safety of electrochemotherapy in treatment of local and/or regional recurrences of gynecological cancers with electrochemotherapy in which standard treatment options have been exhausted.
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 105 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Local or regional relapse of gynecological tumors in which standard treatment options have been exhausted.
- •Age more than
- •Life expectancy more than 3 month.
- •Performance status Karnofsky ≥ 70 or WHO < or
- •Treatment free interval minimum 2 weeks.
- •Patient must be mentally capable of understanding the given information and regarding treatment and any adverse reactions that may occur during treatment.
- •Patient must give informed consent.
- •Patient must be discussed at the multidisciplinary team before entering the trial.
- •Patient should be suitable for anesthesia.
排除标准
- •Visceral, bone or diffuse metastases.
- •Life-threatening infection and/or heart failure and/or liver failure and/or other severe systemic pathologies.
- •Significant reduction in respiratory function.
- •Age less than 18 years.
- •Coagulation disturbances (those who do not respond on standard treatment with vitamin-K or fresh frozen plasma).
- •Cumulative dose of ≥ 400 mg/m2 bleomycin received.
- •Impaired kidney function (creatinin > 150 µmol/l).
- •Patients with epilepsy.
- •Patient incapable of understanding the aim of the study or disagree with the entering into the clinical study.
结局指标
主要结局
Effectiveness of electrochemotherapy according to RECIST 1.1 criteria.
时间窗: Changes from baseline regularly up to 24 months
Effectiveness of electrochemotherapy in the treatment of local or regional recurrences of gynecological tumors in which standard treatment options have been exhausted. Effectiveness will be evaluated according to RECIST 1.1 criteria.
次要结局
- Safety of electrochemotherapy according to CTCAE v5.0 criteria.(during hospitalization and up to 24 months)
研究者
研究点 (2)
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