招募患者：PD-1抗体（BMS-936558）在中国晚期或复发性实体瘤受试者中的I、II期、开放性临床研究

2015-12-27 MedSci MedSci原创

1. 试验药物简介 PD-1抗体(programmed death 1)程序性死亡受体1，是一种重要的免疫抑制分子。本试验药物是百时美施贵宝（BMS）研发的Nivolumab。本试验的适应症是晚期或复发性实体瘤的中国受试者（包括但不限于非小细胞肺癌、胃癌、鼻咽癌、食管癌）。 2. 试验目的本研究的目的是评估nivolumab治疗中国晚期或复发性实体瘤受试者的安全性和疗

1. 试验药物简介

PD-1抗体(programmed death 1)程序性死亡受体1，是一种重要的免疫抑制分子。本试验药物是百时美施贵宝（BMS）研发的Nivolumab。

本试验的适应症是晚期或复发性实体瘤的中国受试者（包括但不限于非小细胞肺癌、胃癌、鼻咽癌、食管癌）。

2. 试验目的

本研究的目的是评估nivolumab治疗中国晚期或复发性实体瘤受试者的安全性和疗效。

3. 试验设计

试验分类：安全性

试验分期：其它

设计类型：单臂试验（没有对照组）

随机化：非随机化

盲法：开放

试验范围：国内试验

试验人数; 56

用法：注射液；规格10mg/ml/瓶；静脉输注，每14天输注1次，每次输注60分钟，每次3mg/kg或1mg/kg，每8周一个治疗周期。用药时程：一直治疗直至疾病进展、发生不可接受的毒性、撤回知情同意或研究结束。

4. 入选标准

1 患有晚期或复发性实体瘤的中国受试者（包括但不限于非小细胞肺癌、胃癌、鼻咽癌、食管癌）

5. 排除标准

1 有脑转移的受试者需排除，除非研究者判断入选时临床稳定2周以上

2 有癌性脑膜炎的受试者需排除

6. 医院和研究者信息

姓名	张力	职称	主任医师、教授
电话	86-20-87343458	Email	zhangli@sysucc.org.cn
邮政地址	广州市东风东路651号	邮编	510060
单位名称	中山大学肿瘤防治中心

7．伦理委员会信息

序号	名称	审查结论	审查日期
1	中山大学肿瘤防治中心医学伦理委员会	同意	2015-12-14

2015年12月14日通过伦理审查，意味着病人的招募应该是在元旦后。

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2016-10-09 忠诚向上

好好看看

56 0
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2016-09-14 黄国兴

怎样参于受试？

59 0
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2016-09-14 黄国兴

怎样参于受试？

48 0
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2016-06-11 hb2008ye

#复发性#

30 0
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2016-06-13 1def88e4m69(暂无匿称)

我有病人就入组

80 0
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2016-02-28 ellenli

怎么入组啊

105 0
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2015-12-29 马里奥8433

支持

75 0
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2015-12-29 aoppolle

终于中国内地也有临床研究了

81 0
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2015-12-29 canlab

#BMS#

33 0
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2015-12-29 xinmeili

#受试者#

24 0

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招募患者：PD-1抗体（BMS-936558）在中国晚期或复发性实体瘤受试者中的I、II期、开放性临床研究

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