NCT06739031招募中不适用
A Multi-center, Single-group Clinical Trial to Evaluate the Efficacy and Safety of Pulsed Electric Field (PEF) Ablation Devices in the Treatment of Lung Tumors
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- 6-month complete ablation rate
研究概览
简要总结
The goal of this clinical trial is to verify the efficacy and safety of pulsed electric field (PEF) treatment of early-stage unreseectable non-small cell lung cancer(NSCLC) patients.
The main questions it aims to answer are:
- Safety of PEF treatment of early-stage unreseectable NSCLC patients.
- Locoregional control of ablated lesions.
- Survival and quality of life assessment of early-stage unreseectable NSCLC patients.
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
- •(all requirements must be met at the same time):
- •1. Age ≥ 18 years old;
- •Pathological diagnosis of non-small cell lung cancer, with the maximum diameter of the tumor ≤ 3 cm and the number ≤ 3;
- •ECOG score ≤ 2 points;
- •According to the evaluation of the researcher, it is technically feasible to perform ablation treatment on the lesion;
- •The subject agrees to receive ablation treatment and signs the informed consent form.
排除标准
- •(if any of the above conditions are met, the patient will be excluded):
- •The subject cannot tolerate or refuses general anesthesia;
- •Has a history of severe allergic reactions;
- •Has contraindications to bronchoscopy or refuses bronchoscopy;
- •5. Has active implants in the chest cavity or metal implants in the lung to be treated;
- •Uncorrectable coagulation abnormalities (INR>1.5 or APTT>1.5 ULN), with bleeding tendency; anticoagulant therapy and/or antiplatelet drugs are discontinued before ablation for no longer than the prescribed safety period; platelets <50×10^9/L;
- •Severe liver and kidney dysfunction, assessed by the researchers as unsuitable for inclusion;
- •Accompanied by infectious diseases that cannot be effectively controlled;
- •Subjects with other severe lung diseases (including severe interstitial pneumonia, pulmonary fibrosis, pulmonary fibrosis combined with emphysema, atelectasis, etc.), assessed by the researchers as unsuitable for inclusion
- •Acute cardiovascular and cerebrovascular accidents such as acute cerebral infarction, acute coronary syndrome, etc. within 3 months;
- •Subjects with severe cardiac dysfunction; history of severe arrhythmias in the past 2 years, including rapid atrial arrhythmias, any rapid ventricular arrhythmias; history of II degree type II or III degree atrioventricular block; and sinus bradycardia with a heart rate of less than 45 beats per minute, etc.;
- •Subjects have participated in or are participating in other clinical trials within three months;
- •Pregnant, lactating women, or women who plan to become pregnant during the study;
- •Subjects determined by the researchers to have other conditions that are unsuitable for inclusion.
研究组 & 干预措施
PEF Treatment
Experimental
干预措施: PEF Treatment (Device)
结局指标
主要结局
6-month complete ablation rate
时间窗: 6 months
次要结局
- Technical success rate(immediately after the PEF ablation treatment)
- 6-month pulmonary progression-free survival rate(6 months after the first PEF ablation treatment)
- 12-month complete ablation rate(12 months after the first PEF ablation treatment)
- 12-month pulmonary progression-free survival rate(12 months after the first PEF ablation treatment)
- 12-month overall survival rate(12 months after the first PEF ablation treatment)
研究者
研究点 (2)
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