New Method of Treatment for Thoracoscopy or Bronchoscopy by Suspension of Fine Powder of Talcum and Afatinib is Used in Patients With Positive Mutation of EGFR in Non-Small Cell Lung Carcinoma (NSCLC)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- The effectiveness of the procedure of dry pleurodesis through a thoracoscope
研究概览
简要总结
In non-small cell lung cancer and metastases in the pleural cavity, pathological effusion is formed.
Currently, the most common and effective method of obliteration of the pleural cavity is pleurodesis with talcum powder.
Talc, when it surface of the pleura, causes chemical inflammation that leads to the soldering of the lungs and chest wall. As a result, the liquid ceases to accumulate.
The addition of a therapeutic dose of afatinib to talc not only blocks effusion into the pleural cavity, but also reduces tumor and metastatic processes.
详细描述
The proposed procedure for dry pleurodesis consists of one stage.
Talc is introduced into the pleural cavity in several ways:
- Drainage - a tube is inserted into the pleural cavity through a puncture in the chest, and then a pasty talcum is delivered into the cavity, which spreads through the cavity during the change of the patient's body position.
- Talcum powder - under the control of thoracoscopy, dry talc is blown into the pleural cavity of the patient, which allows him to evenly distribute and significantly increases the effectiveness of the procedure.
In this Clinical Trial investigators will use the method of thoracoscopy - the blow in of talcum powder and therapeutic dose of Afatinib. Before injection, a suspension of talc and afatinib is subjected to the procedure of pharmaceutical mixing.
The operation is well tolerated by participants and lasts no more than 30 minutes. The effectiveness of the method is 90%.
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
盲法说明
None (Open Label)
入排标准
- 年龄范围
- 21 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Non-small cell lung cancer with positive mutation of EGFR verified
- •Malignant pleural effusion
- •Recurrent pleural effusion
- •Complete lung expansion (> 80%) after puncture emptying confirmed by chest radiography.
- •Karnofsky index > 50
- •Agreed to participate in the study and sign an Informed Consent
排除标准
- •Radiotherapy not earlier than 3 months before the pleurodesis procedure
- •Previous surgeries on the same hemitorace
- •Thrombocytopenia or coagulation disorders
- •Trapped lung syndrome
- •Patients with estimated life expectancy < 4-8 weeks
- •Pleural or active systemic infection
研究组 & 干预措施
Talcum powder & Afatinib
Talcum powder 4 g + Afatinib 0,4 g. Is entered once
干预措施: Afatinib (Drug)
Talcum powder & Afatinib
Talcum powder 4 g + Afatinib 0,4 g. Is entered once
干预措施: Talcum powder (Drug)
结局指标
主要结局
The effectiveness of the procedure of dry pleurodesis through a thoracoscope
时间窗: up to 90 days
Evaluation of the effectiveness of the dry pleurodesis procedure in combination with talc and afatinib with the introduction of a powder suspension through a thoracoscope. The assessment is performed by CT (computed tomography) of each participant twice: 30 days from the day of the procedure and 90 days later.
次要结局
未报告次要终点