NCT01002092Unknown2 期
A Randomized, Controlled Multicenter Trial of Endostar Combined With Chemotherapy for Treatment of Osteosarcoma
Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd4 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2009年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 160
- 试验地点
- 4
- 主要终点
- Progression Free Survival
研究概览
简要总结
Purpose: This study will assess the safety and efficacy of Endostar combined with chemotherapy in osteosarcoma patients.
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
- 12 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically confirmed osteosarcoma, who have no evidence of metastasis
- •At least one measurable lesion
- •Life expectancy > 3 months
- •ECOG performance status 0-2
- •Adequate hematologic, cardiac, renal, and hepatic function
- •Patients with prior chemotherapy should have at least 4 weeks clearance period before entering this study
排除标准
- •Evidence of metastasis
- •Serious infection
- •Evidence of bleeding diathesis
- •Significant cardiovascular disease
- •Pregnant or lactating woman
- •Allergic to E.coli preparation
研究组 & 干预措施
Endostar plus Chemotherapy
Experimental
干预措施: Endostar (Drug)
Chemotherapy
Active Comparator
干预措施: Chemotherapy (Drug)
Endostar plus Chemotherapy
Experimental
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: 5 years
次要结局
- Clinical Response Rate(end of the first cycle)
- Overall Survival(5 years)
- Limb Salvage Rate(end of the first cycle)
- Clinical Benefit Response(end of the first cycle)
- Quality of Life(after 4 cycles)
研究者
研究点 (4)
Loading locations...
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