NCT04417933Unknown早期 1 期
A Prospective, Single-center, Single-arm, Exploratory Study on the Treatment of Recurrent Glioblastoma With Tumor Electric Fields Treatment System
Xiangya Hospital of Central South University1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2020年4月7日最近更新:
适应症
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- The treatment-related adverse events
研究概览
简要总结
This early phase I trial will investigate the safety and feasibility of applying the Tumor Electric Fields Treatment System to subjects with recurrent glioblastoma.
详细描述
Subjects who have previously completed radiotherapy and at least two cycles of chemotherapy with imaging or pathological evidence of tumor recurrence will receive Tumor Electric Fields Treatment System. The main objective is to evaluate the safety of applying the Tumor Electric Fields Treatment System to subjects with recurrent GBM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with pathological diagnosis of glioblastoma at first surgery (WHO Grade IV, supratentorial location);
- •Age between 18 and 65 years, male or female;
- •Previously completed radiotherapy and at least two cycles of chemotherapy;
- •With imaging or pathological evidence of tumor recurrence;
- •Karnofsky performance score (KPS) score ≥ 70 before intervention;
- •With a life expectancy more than 3 months;
- •Adopted effective contraceptive measures at child-bearing age;
- •Provided written informed consent.
排除标准
- •Patients unwilling to use the equipment ≥ 18h per day;
- •With poor compliance or live too far from the research center, who cannot keep regular follow-up or adjust the electrode position of the treatment equipment, and who refuse to receive follow-up to terminal survival;
- •With poor healing of scalp wound, poor scalp condition, large skull defect or other cases where electrodes are not suitable for wearing;
- •Within 3 months from radiotherapy;
- •Within 4 weeks from the last cycle of chemotherapy;
- •Within 4 weeks from surgery for recurrence;
- •Participated in other clinical trials.
- •Pregnant;
- •Epilepsy symptoms not effectively controlled;
- •Blood and biochemical indicators in the following range: A. Liver function impairment: AST or ALT > 3 times the upper limit of normal; B. Total bilirubin> upper limit of normal value; C. Renal impairment: serum creatinine>1.7mg /dL (>150 mol/L); D. Coagulopathy: PT or APTT >1.5 times normal; E. Platelets counts < 100x10^9/L; F. Absolute neutrophils count < 1x10^9/L; G. Hemoglobin < 100g/L;
- •With severe infectious diseases, such as acute severe infection and HIV positive;
- •Other conditions, such as an implanted cardiac pacemaker or deep brain stimulator, severe intracranial edema, increased intracranial pressure resulting in midline shift>5mm, clinically significant papilledema, or reduced level of consciousness, allergy to conductive coupling agent, gel, and other serious life-threatening diseases.
- •Other circumstances considered inappropriate to participate in the research by the investigator.
结局指标
主要结局
The treatment-related adverse events
时间窗: 12 months
Number of patients who experienced a treatment-related adverse event.
Time to Progression
时间窗: 12 months
Time to progression of patients with recurrent glioblastoma.
Overall Survival Rate
时间窗: 12 months
Number of patients alive at 12 months.
次要结局
未报告次要终点
研究者
研究点 (1)
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