NCT04905056招募中2 期
A Prospective, Two-center, Single Arm Phase II Clinical Study to Evaluate Safety and Effectiveness of Ablation Therapy in the Treatment of Lung Cancer Presenting as Ground-glass Nodules
Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年1月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- progression free survival
研究概览
简要总结
A prospective, two-center, single arm phase II clinical study to evaluate safety and effectiveness of ablation therapy in the treatment of lung cancer presenting as ground-glass nodules
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 85 years;
- •GGO is diagnosed by lung CT and failure to subside after 3 months (the patient having been re-examined by thin-section CT);
- •The maximum diameter of the GGO is bigger than 8mm and smaller than 3cm;
- •For single GGO: obvious progress was observed in pure GGO or the solid component of mixed ground glass nodules was more than or equal to 2 mm
- •The patients were unable to tolerate the operation for various reasons or multiple grinding glass nodules, operation can not be completely removed; or patients had received surgery in ipsilateral chest
- •The patient is able to understand and comply with the study and has provided written informed consent
排除标准
- •Patients who participated in any drug and / or medical device clinical trials within one month before the trial
- •had severe disease conditions
- •allergy to narcotic drugs
- •had other autoimmune disease
- •dementia or cognitive impairment can't cooperate with researchers
- •any local treatment other than ablation was received within 4 weeks before the study
结局指标
主要结局
progression free survival
时间窗: 1 years
One year progression free survival after radiofrequency ablation of ground glass nodules
次要结局
- overall survival(1 years, 3 years, 5years)
研究者
Xi Junjie
professor
Shanghai Zhongshan Hospital
研究点 (1)
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