A Prospective Clinical Trial of Tumor Immunomodulation Using Tumor-Treating Fields (TTFields) in Patients With Early-Stage Resectable Lung Adenocarcinoma
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 12
- 试验地点
- 14
- 主要终点
- Adverse events, severity and frequency
研究概览
简要总结
The researchers are doing this study to find out if treatment with TTFields using the NovoTTF-200T System is safe and practical (feasible) before surgical removal (resection) of lung adenocarcinoma (ADC). The researchers will also look at how the treatment may help the body's immune system to fight cancer.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant (or legally acceptable representative [LAR], if applicable) provides written informed consent for the study.
- •The participant is ≥22 years of age on the day of signing informed consent.
- •The participant has clinical stage 1A2, 1A3 or IB biopsy-proven lung ADC and is eligible for anatomical resection.
- •The participant has a lung nodule >1 cm and suspected lung ADC with a plan to undergo biopsy.
- •The participant with multiple nodules has one nodule that meets the criteria.
- •The participant has no history of prior malignancy in the chest or has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.
排除标准
- •Patients receiving therapy for concurrent active malignancy
- •Patients with a history of cardiac arrhythmias and/or pacemaker use
- •Patients with lung nodules <1cm
- •Patients with lung nodules that are pure ground glass opacities (GGOs) of any size
- •Patients with lung nodules that are <50% solid of any size
研究组 & 干预措施
NovoTTF-200T System Tumor-Treating Fields (TTFields)
Following pathological confirmation on of lung ADC, patients will proceed with TTFields treatment. The NovoTTF-200T System is an investigational medical device delivering 150 kHz TTFields to the patient's chest. The device is applied continuously for an average duration of 18 hours per day for 3 weeks (+/- 1 week).
干预措施: NovoTTF-200T System (Device)
结局指标
主要结局
Adverse events, severity and frequency
时间窗: 1 year
based on Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
次要结局
未报告次要终点