Efficacy and Safety of Intrapleural Bevacizumab Versus Pulvis Talci in Malignant Pleural Effusion, A Randomized, Multicenter Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 183
- 试验地点
- 1
- 主要终点
- Changes in chest drainage
研究概览
简要总结
Patients with Malignant pleural effusion can be diagnosis advanced cancer. Currently recognized as the most reliable method to control malignant pleural effusion is pleural fixed or thoracic catheter drainage. The most effective pleural fixed agent is pulvis talci, but there are about 30% relapse rate. Thoracic drainage can lead to some complications, such as chest infections, catheter migration and blockage etc. The investigators need a reliable methods to solve dyspnea and other symptoms caused by malignant pleural effusion, and improve quality of life. The purpose of this study was to determine the efficacy and Safety of intrapleural Bevacizumab versus pulvis talci as treatment for malignant pleural effusions (MPE) in patients.
详细描述
Background： Patients with Malignant pleural effusion can be diagnosis advanced cancer. Currently recognized as the most reliable method to control malignant pleural effusion is pleural fixed or thoracic catheter drainage. The most effective pleural fixed agent is pulvis talci, but there are about 30% relapse rate. Thoracic drainage can lead to some complications, such as chest infections, catheter migration and blockage etc. The investigators need a reliable methods to solve dyspnea and other symptoms caused by malignant pleural effusion, and improve quality of life. The purpose of this study was to determine the efficacy and Safety of intrapleural Bevacizumab versus pulvis talci as treatment for malignant pleural effusions (MPE) in patients.
Methods:
A unblended, randomized study to compare the inhibition of two treatment methods in malignant pleural effusion. Consecutive 183 patients were randomly assigned to two groups, A group is Bevacizumab200mg by intrapleural administration; B group is injected pulvis talci with closed thoracic drainage.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnose malignant pleural effusions by:
- •Diagnose malignant pleural neoplasms by histopathology
- •Recurrent pleural effusion, Histologically or cytologically confirmed diagnosis of cancer
- •Written informed consent
排除标准
- •<18years of age
- •Expected survival <3 months
- •Chest infection, chylothorax, pleurodesis or ipsilateral lung surgery once
- •Planned chemotherapy
- •Pregnancy or breast-feeding (women of child-bearing potential)
- •Not signed informed consent or non-compliance with treatment protocols
研究组 & 干预措施
Pulvis talci
Pulvis talci 4g by intrapleural administration
干预措施: Pulvis talci (Drug)
Bevacizumab
Bevacizumab200mg by intrapleural administration
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Changes in chest drainage
时间窗: up to 3months
Observed chest drainage every day
次要结局
- the average daily VAS defining breathlessness(up to 1 year)
- Average daily thoracalgia assessed using VAS score(up to 1 year)
- percentage of adverse reactions(up to 1 year)
- Length of Stay(up to 1 year)
研究者
Xiaofei Li
chief physician
Tang-Du Hospital