NCT01612286Unknown2 期
A Phase II Clinical Study of Endostar Combination With Chemotherapy in the Metastatic Nasopharyngeal Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- progress free survival(PFS)
研究概览
简要总结
The investigators designed this study to evaluate the efficiency and the acute toxicities of recombinant human endostatin (endostar) combined with chemotherapy in the metastatic nasopharyngeal carcinoma (NPC).
详细描述
To evaluate the progression free survival (PFS), overall survival (OS), Acute adverse reaction of recombinant human endostatin (endostar) combined with chemotherapy to the metastatic nasopharyngeal carcinoma (NPC).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed metastatic NPC patient who have received radiotherapy or chemoradiotherapy with an at least 6 months interval
- •Have measurable lesions
- •No dysfunction of the major organs
- •Can understand this study and give a signed informed consent certificates
- •without a history of allergic reaction to the biological agents
排除标准
- •Pregnant or lactating women; Women of child-bearing age without contraception
- •with a Serious infection or dysfunction of the major organs
- •have taken other antitumor drugs during the period of 30 days ahead of this clinical trial
- •allergic to the Escherichia coli preparations
- •Cann't understand this study and give a signed informed consent certificates
研究组 & 干预措施
endostatin
Experimental
chemotherapy concurrently with endostatin
干预措施: endostatin (Drug)
结局指标
主要结局
progress free survival(PFS)
时间窗: 1 year and 2years
PFS means assignament to the date of any local or distant progress of the disease useing Kaplan-Meier caculate the progress free survival rates
次要结局
- overall survival(OS)(baseline to date of death from any cause)
- Adverse events(participants will be followed for the duration of hospital stay,an expected average of 100 days and every 3 months thereafter for 1 year)
研究者
研究点 (1)
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