Safety and Tolerability of TTFields for Patients With Brain Metastases After the Standard Treatment Fails: a Prospective, Single-center, Single-arm Study
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
Brain metastasis is a very common disease with poor prognosis, 20% cancer will develop brain metastases(BM), up to 40% by autopsy. Great advances have made with the application of targeting therapy, immunotherapy, chemotherapy, whole brain radiation and radiosurgery, however, treated patients were finally suffered from drug/radiation resistance and rapid recurrence. Tumor treating fields (TTFields) is one of the standard combination treatment for GBM, and some researchers believe that TTFields can effectively inhibit patient-derived lung adenocarcinoma brain metastasis cells progression in vitro. In this study, the investigator attempts to evaluate the safety, and tolerability of TTFields in adult participants diagnosed with Drug/Radiation resistant BM.
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 are diagnosed as brain metastases by Xiangya Hospital multidisciplinary team;
- •age from 18 to 65 year-old;
- •patients have been progressed from standard therapy (drug/radiation resistance)
- •KPS more than 70 score;
- •anticipated OS more than 3 months;
- •signed consent form.
排除标准
- •unable to take TTFields more than 18 hours each day;
- •unable to follow-up till progression;
- •the scalp wound is not well healed, the head skin condition is not good, the skull has a large area defect, or other situations that are not suitable for wearing electrodes
- •pregnant women;
- •last drug within 4 weeks, last radiation within 3 months, take other trials;
- •other heavy diseases like heavy infection;
- •other condition: Such as breastfeeding, installation of cardiac pacemakers, brain stimulators, severe intracranial edema, increased intracranial pressure leading to midline structures exceeding 5 mm, optic nerve head edema, disturbance of consciousness, etc., allergies to conductive coupling agents, gels, etc.
- •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;
- •other conditions physicians not suggest to take the trial
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 brain metastases
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