Open-labeled, Randomized, Multicenter Phase III Study of Adjuvant Chemotherapy Comparing Bevacizumab Plus Cisplatin With Cisplatin Regimen in Malignant Pleural Effusion of Advanced Stage Non-Small-Cell Lung Cancer Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Number of Participants With "Complete Response" and "Partial Response"
研究概览
简要总结
To determine the efficacy and Safety of intrapleural Bevacizumab and cisplatin as a treatment for malignant pleural effusions (MPE) in patients with non-small cell lung cancer (NSCLC).
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with advanced recurrent or progressive NSCLC proven cytohistologically
- •Karnofsky performance status (KPS) ≥60
- •Life expectancy ≥ 2 months
- •No history of severe diseases of major organs including liver, heart, and kidney
- •No previous intrapleural therapy
- •Written informed consent
排除标准
- •Active thoracic cavity or systemic bleeding
- •Active pleural or systemic infection.
- •Known sensitivity to Bevacizumab or Cisplatin
- •Refusal to participate in the study.
研究组 & 干预措施
Bevacizumab & Cisplatin
Bevacizumab 300mg plus Cisplatin 30mg by intrapleural given every two weeks
干预措施: Bevacizumab (Drug)
Bevacizumab & Cisplatin
Bevacizumab 300mg plus Cisplatin 30mg by intrapleural given every two weeks
干预措施: Cisplatin (Drug)
Cisplatin
Cisplatin 30mg by intrapleural given every two weeks
干预措施: Cisplatin (Drug)
结局指标
主要结局
Number of Participants With "Complete Response" and "Partial Response"
时间窗: from randomization, This treatment was given every two weeks,responses were made by biweekly
Response assessed by type-B ultrasonic tests; Complete remission (CR) was considered when the accumulated fluid had disappeared and was stable for at least four weeks; partial remission (PR) was considered when \>50% of the accumulated fluid had disappeared, symptoms had improved, and the remaining fluid had failed to increase for at least four weeks; The total efficiency ORR was calculated by taking the sum of CR+PR
次要结局
- Median Progression Free Survival (PFS)(baseline to biweekly,until disease progression)
- Adverse Reactions(Up to 1 month after the last treatment)
- Qualify of Life (QoL)(baseline to biweekly,until death)
- Overall Survival (OS)(randomization to four weeks,until death)
研究者
DuNan
director of oncology department in PLA 304 hospital
Chinese PLA General Hospital