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马来酸吡咯替尼片治疗HER2变异晚期非小细胞肺腺癌的前瞻性、多中心、非干预登记性临床研究
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注册号:

Registration number:

ChiCTR1800020262 

最近更新日期:

Date of Last Refreshed on:

2018-12-21 

注册时间:

Date of Registration:

2018-12-21 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

马来酸吡咯替尼片治疗HER2变异晚期非小细胞肺腺癌的前瞻性、多中心、非干预登记性临床研究 

Public title:

A multicenter study for pyrotinib maleate in the treatment of advanced non-small cell lung adenocarcinoma with HER2 mutation 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

马来酸吡咯替尼片治疗HER2变异晚期非小细胞肺腺癌的 前瞻性、多中心、非干预登记性临床研究 

Scientific title:

A multicenter study for pyrotinib maleate in the treatment of advanced non-small cell lung adenocarcinoma with HER2 mutation 

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:

宋正波 

研究负责人:

张沂平 

Applicant:

Zhengbo Song 

Study leader:

Yiping Zhang 

申请注册联系人电话:

Applicant telephone:

+86 13857153345 

研究负责人电话:

Study leader's telephone:

+86 13750881678 

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:

li168466320@163.com 

研究负责人电子邮件:

Study leader's E-mail:

zjzlyy16@163.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:

杭州市拱墅区半山东路1号 

研究负责人通讯地址:

杭州市拱墅区半山桥广济路38号 

Applicant address:

1 Banshan Road East, Gongshu District, Hangzhou, Zhejiang, China 

Study leader's address:

1 Banshan Road East, Gongshu District, Hangzhou, Zhejiang, 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:

浙江省肿瘤医院 

Applicant's institution:

Zhejiang Cancer Hospital 

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:

IRB-2018-215 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

浙江省肿瘤医院医学伦理委员会 

Name of the ethic committee:

Zhejiang Cancer Hospital Medical Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-11-30 

伦理委员会联系人:

徐伟珍 

Contact Name of the ethic committee:

Weizhen Xu 

伦理委员会联系地址:

杭州市拱墅区半山东路1号 

Contact Address of the ethic committee:

1 Banshan Road East, Gongshu District, Hangzhou, Zhejiang, 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:

浙江省肿瘤医院 

Primary sponsor:

Zhejiang Cancer Hospital 

研究实施负责(组长)单位地址:

杭州市拱墅区半山东路1号 

Primary sponsor's address:

1 Banshan Road East, Gongshu District, Hangzhou, Zhejiang, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

自筹经费 

Source(s) of funding:

self-financing 

研究疾病:

肺癌 

Target disease:

Lung Cancer 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

II期临床试验 

Study phase:

研究目的:

观察和评价马来酸吡咯替尼用于HER2变异复治晚期非小细胞肺癌的有效性和安全性 

Objectives of Study:

To evaluate the efficacy and safety of pyrotinib for the treatment of advanced non-small cell lung cancer with HER2 mutation 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

1.年龄≥18岁; 2.ECOG 为0~3; 3.经组织学或细胞学确诊的非小细胞肺腺癌(NSCLC,腺癌),按照国际肺癌研究协会(IASLC)2009年第七版分期标准(IASLC 2009)诊断为ⅢB期或Ⅳ期; 4.经临床认可的方法(包括PCR法,FISH法、免疫组化法及NGS方法)检测出HER2变异(包括扩增、突变及过表达等); 5.依据RECIST 1.1标准,至少有一个可测量靶病灶存在; 6.由于不对研究进行干预,患者可以一线或多线使用吡咯替尼; 7.研究者根据影像学判断(RECIST 1.1标准),入组前接受末次抗肿瘤方案治疗后或治疗中发生进展的患者; 8.签署知情同意,同意采集患者的临床疗效和信息。 

Inclusion criteria

1. Aged at least 18 years old; 2. Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-3; 3. Histologically or cytologic confirmed Non-small cell lung cancer, Phase IIIB or IV according to IASLC 2009; 4. Confirmed HER2 mutation by Central Laboratoryincluded PCRFISH, NGS; 5. At least one measurable lesion exists.(RECIST 1.1); 6. With no intervention in the study, patients may use pyrotinib in first or more lines; 7. Failed prior therapies.(RECIST 1.1); 8. Signed informed consent. 

排除标准:

1.存在无法通过引流或其他方法控制的第三间隙积液(如大量胸水和腹水),无法评价临床治疗疗效; 2.首次服用研究药物前1周内接受过针对非小细胞肺腺癌的放疗、化疗、手术治疗或其他靶向治疗且未从既往治疗中进展; 3.患者不适合参加本观察性研究的其他任何情况。 

Exclusion criteria:

1. There is a third interstitial fluid (such as a large amount of pleural effusion and ascites) that cannot be controlled by drainage or other methods, and the clinical treatment effect cannot be evaluated; 2. Radiotherapy, chemotherapy, surgery or other targeted therapy for non-small cell lung adenocarcinoma within 1 week prior to the study and did not progress from previous treatment; 3. The other conditions that patients are not eligible to enroll this observational study. 

研究实施时间:

Study execute time:

From2019-01-02To 2021-01-02 

征募观察对象时间:

Recruiting time:

From2019-01-02To 2020-01-02 

干预措施:

Interventions:

组别:

观察组

样本量:

60

Group:

Case series

Sample size:

干预措施:

吡咯替尼

干预措施代码:

Intervention:

pyrotinib

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

浙江省肿瘤医院 

单位级别:

三甲医院 

Institution
hospital:

Zhejiang Cancer Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

无进展生存期

指标类型:

主要指标 

Outcome:

PFS

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

客观缓解率

指标类型:

次要指标 

Outcome:

ORR

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疾病控制率

指标类型:

次要指标 

Outcome:

DCR

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

总生存期

指标类型:

次要指标 

Outcome:

OS

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

无随机

Randomization Procedure (please state who generates the random number sequence and by what method):

Non-random

盲法:

N/A

Blinding:

N/A

是否共享原始数据:

IPD sharing

否No

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

下载

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

download

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

病历记录表

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

CRF

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2018-12-21
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