NCT01327235已完成2 期
A Randomized Controlled Multicenter Trial of Endostar and/or Cisplatin in Patients With Malignant Pleural Effusion or Ascites
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 336
- 试验地点
- 3
- 主要终点
- Objective Response Rate
研究概览
简要总结
The objective of this study is to compare the efficacy of Endostar/cisplatin with cisplatin alone or Endostar alone in patients with malignant pleural effusion or ascites.
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
- •Histological or cytological diagnosis of thoracic or abdominal tumor
- •At least medium amount of malignant pleural effusion or ascites
- •ECOG Performance Status 0-2
- •Life expectancy ≥ 2 months
- •Adequate hematologic, cardiac, renal, and hepatic function
- •No major surgery within 4 weeks prior to this study
- •Written informed consent
排除标准
- •Patients with central nervous system (CNS) metastases
- •Evidence of bleeding diathesis, serious infection
- •Evidence of myocardial infarction, unstable angina or cardiac insufficiency
- •Presence of serious COPD and/or respiratory failure
- •Allergic to study drug
- •Pregnant or lactating women
- •Participation in other clinical trials within 30 days prior to this study
研究组 & 干预措施
Endostar
Active Comparator
干预措施: Endostar (Drug)
Cisplatin
Active Comparator
干预措施: Cisplatin (Drug)
Endostar and Cisplatin
Experimental
干预措施: Endostar (Drug)
Endostar and Cisplatin
Experimental
干预措施: Cisplatin (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: baseline to measured progressive disease, every three weeks
WHO criteria
次要结局
- Time to Progression(baseline to every three weeks until disease progression)
- Quality of Life(baseline to every three weeks)
- Incidence of Adverse Events(Up to 1 month after the last treatment)
研究者
研究点 (3)
Loading locations...
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