NCT01410370Unknown2 期
Phase II Study of Continuous Endostar Infusion Combined With Radiotherapy for the Treatment of Patients With Brain Metastases
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
The aim of this study is to evaluate the clinical efficacy and safety of continuous Endostar infusion combined with radiotherapy for treatment of brain metastases.
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
- •Histologically confirmed malignancy with presence of intraparenchymal brain metastases
- •Karnofsky performance status ≥ 40
- •Measurable disease according to RECIST criteria
- •Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 90g/L
- •Renal function: Cr ≤ 2.0×ULN
- •Hepatic function: BIL ≤ 2.0×ULN, ALT/AST ≤ 5.0×ULN
- •Adequate cardiac function
- •Life expectancy ≥ 3 months
排除标准
- •Evidence of bleeding diathesis or serious infection
- •Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension)
- •Uncontrollable mental and nervous disorders
- •Pregnant or lactating women
研究组 & 干预措施
treatment
Experimental
Radiotherapy plus Endostar
干预措施: 6MV-X ray (Radiation)
treatment
Experimental
Radiotherapy plus Endostar
干预措施: Endostar (Drug)
control
Active Comparator
Radiotherapy
干预措施: 6MV-X ray (Radiation)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: 1 month after initial treatment
次要结局
- Overall Survival(2 year)
- Serum VEGF Levels(at baseline and 1 month after initial treatment)
- VEGF levels in tumor tissue(at baseline and 1 month after initial treatment)
- Incidence of Adverse Events(up to 1 month after last dose)
- Cerebral Edema(1 month after initial treatment)
研究者
研究点 (1)
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