今天是:2019-07-17 星期三

阿帕替尼联合替莫唑胺治疗成人初次复发的原发胶质母细胞瘤的多中心开放随机对照研究
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注册号:

Registration number:

ChiCTR1900020646 

最近更新日期:

Date of Last Refreshed on:

2019-01-11 

注册时间:

Date of Registration:

2019-01-11 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

阿帕替尼联合替莫唑胺治疗成人初次复发的原发胶质母细胞瘤的多中心开放随机对照研究 

Public title:

A multicenter open-label randomized controlled trial for apatinib combined with temozolomide in adult primary glioblastoma at first recurrence 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

阿帕替尼联合替莫唑胺治疗成人初次复发的原发胶质母细胞瘤的多中心开放随机对照研究 

Scientific title:

A multicenter open-label randomized controlled trial for apatinib combined with temozolomide in adult primary glioblastoma at first recurrence 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

张俊平 

研究负责人:

张俊平 

Applicant:

Jun-ping Zhang 

Study leader:

Jun-ping Zhang 

申请注册联系人电话:

Applicant telephone:

+86 010 62856783 

研究负责人电话:

Study leader's telephone:

+86 010 62856783 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

doczhjp@hotmail.com 

研究负责人电子邮件:

Study leader's E-mail:

doczhjp@hotmail.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

北京市海淀区香山一棵松50号 

研究负责人通讯地址:

北京市海淀区香山一棵松50号 

Applicant address:

50 Yi-Ke-Song Road, Haidian District, Beijing, China 

Study leader's address:

50 Yi-Ke-Song Road, Haidian District, Beijing, China 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

首都医科大学三博脑科医院 

Applicant's institution:

Sanbo Brain Hospital, Capital Medical University 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

SBNK-2018-046-01 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

首都医科大学三博脑科医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Sanbo Brain Hospital, Capital Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

李耕子 

Contact Name of the ethic committee:

Geng-zi Li 

伦理委员会联系地址:

北京市海淀区香山一棵松50号 

Contact Address of the ethic committee:

50 Yi-Ke-Song Road, Haidian District, Beijing, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

首都医科大学三博脑科医院 

Primary sponsor:

Sanbo Brain Hospital, Capital Medical University 

研究实施负责(组长)单位地址:

北京市海淀区香山一棵松50号 

Primary sponsor's address:

50 Yi-Ke-Song Road, Haidian District, Beijing, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

首都医科大学三博脑科医院

具体地址:

北京市海淀区香山一棵松50号

Institution
hospital:

Sanbo Brain Hospital, Capital Medical University

Address:

50 Yi-Ke-Song Road, Haidian District, Beijing, China

经费或物资来源:

江苏恒瑞医药股份有限公司 

Source(s) of funding:

Jiangsu Hengrui Pharmaceutical Co., Ltd.  

研究疾病:

复发胶质母细胞瘤 

Target disease:

Recurrent glioblastoma 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

上市后药物 

Study phase:

研究目的:

评价阿帕替尼联合替莫唑胺治疗成人初次复发的原发胶质母细胞瘤的有效性和安全性。 

Objectives of Study:

To evaluate the effect and safety of apatinib combined with temozolomide in adult primary glioblastoma at first recurrence. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel