NCT01368419Unknown2 期
Phase II Study of Continuous Endostar Infusion Combined With Radiotherapy in Esophageal Cancer Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This study is to explore the clinical efficacy of continuous Endostar infusion combined with radiotherapy in esophageal cancer patients.
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
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 previously untreated stage I-III esophageal cancer
- •Measurable disease according to RECIST criteria
- •ECOG Performance Status 0-1
- •The length of esophageal carcinoma ≤ 10 cm
- •Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 90g/L
- •Renal function: Cr ≤ 2.0×UNL
- •Hepatic function: BIL ≤ 2.0×UNL, ALT/AST ≤ 5.0×UNL
排除标准
- •Pregnant or lactating women
- •Evidence of bleeding diathesis, 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
研究组 & 干预措施
Treatment
Experimental
干预措施: Endostar (Drug)
Treatment
Experimental
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: 1 month after treatment
次要结局
- Clinical Benefit Rate (CBR)(1 month after treatment)
- Overall Survival (OS)(2 years)
- Time to Progression (TTP)(every three months until disease progression)
- Serum VEGF Levels(at baseline and 6 weeks)
- Incidence of Adverse Events(up to 3 months)
研究者
研究点 (1)
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