NCT05291403招募中不适用
The Efficacy and Safety Study of Medical Thoracoscope Cryotherapy Combined With Standard First-line Treatment of Advanced Non-small Cell Lung Cancer and Malignant Pleural Effusion: a Multicenter, Prospective, Randomized, Controlled Clinical Trial
Qianfoshan Hospital1 个研究点 分布在 1 个国家目标入组 141 人开始时间: 2022年4月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 141
- 试验地点
- 1
- 主要终点
- pleural progression free survival, P-PFS
研究概览
简要总结
This study intends to investigate the efficacy and safety of medical thoracoscopic cryotherapy combined with standard first-line treatment of advanced non-small cell lung cancer with malignant pleural effusion through a randomized controlled clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years old;
- •Non-small cell lung cancer with pleural metastasis confirmed by histopathology or cytology;
- •ECOG score 0-1;
- •Cardiopulmonary function can tolerate painless thoracoscopic examination;
- •Patients who underwent medical thoracoscopy for pleural effusion at first diagnosis and underwent medical thoracoscopy cryotherapy at the same time of biopsy were also included in the study. Non-small cell lung cancer was confirmed by pathological results;
- •All subjects or their guardians must sign the informed consent before entering the study.
排除标准
- •Expected survival <2 months;
- •Hemoglobin <110g/L, white blood cell count <3×109/L, neutrophil <2.0×109/L, platelet <100×109/L;
- •severe cardiac insufficiency, abnormal liver and kidney function (blood test results of transaminase and creatinine > 1.5 times the normal upper limit);
- •have received chemotherapy or anti-angiogenic drugs (such as bevacizumab, endu, anlotinib, etc.);
- •History of radiotherapy;
- •history of intrathoracic local treatment;
- •multiple serous cavity effusion, or bilateral pleural effusion;
- •patients allergic to erythromycin;
- •the lung cannot be reopened.
结局指标
主要结局
pleural progression free survival, P-PFS
时间窗: up to 2 months
According to Millar's criteria, P-PFS was defined as absence of pleural effusion lasting more than 4 weeks; Or an order of magnitude reduction in pleural effusion (such as large to medium volume, or medium to small volume) lasting more than 4 weeks; Or pleural effusion with no significant change, lasting more than 4 weeks.
次要结局
- Progression-free survival (PFS)(up to 2 months)
- modified Medical Research Council Dyspnea Scale(up to 2 months)
- Total effective rate(up tp 2 months)
- Overall survival time(up to 2 months)
- Adverse reactions(up to 2 months)
研究者
Qian Qi
Doctor
Qianfoshan Hospital
研究点 (1)
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