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: |
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English Acronym: |
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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: |
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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: |
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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): |
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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: |
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申请人所在单位: |
浙江省肿瘤医院 |
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Applicant's institution: |
Zhejiang Cancer Hospital |
是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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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 |
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Name of the ethic committee: |
Zhejiang Cancer Hospital Medical Ethics Committee |
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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 |
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Contact Name of the ethic committee: |
Weizhen Xu |
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伦理委员会联系地址: |
杭州市拱墅区半山东路1号 |
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Contact Address of the ethic committee: |
1 Banshan Road East, Gongshu District, Hangzhou, Zhejiang, China |
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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: |
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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: |
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Target disease code: |
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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: |
2 |
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: |
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Description for medicine or protocol of treatment in detail: |
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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: |
从From2019-01-02至To 2021-01-02 |
征募观察对象时间: Recruiting time: |
从From2019-01-02至To 2020-01-02 |
干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
尚未开始 Not yet recruiting |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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随机方法(请说明由何人用什么方法产生随机序列): |
无随机 |
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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 |