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A national, multi-center real world study of camrelizumab-based therapy in patients with metastatic NSCLC after failed first-line treatment with camrelizumab plus chemotherapy
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注册号:

Registration number:

ChiCTR2200058209 

最近更新日期:

Date of Last Refreshed on:

2022-04-01 

注册时间:

Date of Registration:

2022-04-02 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

卡瑞利珠单抗跨线联合方案治疗卡瑞利珠单抗联合化疗一线失败后的转移性NSCLC的全国多中心真实世界研究 

Public title:

A national, multi-center real world study of camrelizumab-based therapy in patients with metastatic NSCLC after failed first-line treatment with camrelizumab plus chemotherapy 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

卡瑞利珠单抗跨线联合方案治疗卡瑞利珠单抗联合化疗一线失败后的转移性NSCLC的全国多中心真实世界研究 

Scientific title:

A national, multi-center real world study of camrelizumab-based therapy in patients with metastatic NSCLC after failed first-line treatment with camrelizumab plus chemotherapy 

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:

廖梓伊 

研究负责人:

周进 

Applicant:

Ziyi Liao 

Study leader:

Jin Zhou 

申请注册联系人电话:

Applicant telephone:

17708177615 

研究负责人电话:

Study leader's telephone:

17708177615 

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:

ziyiliao163@163.com 

研究负责人电子邮件:

Study leader's E-mail:

zhoujt521@163.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

四川省肿瘤医院 

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:

四川省成都市高新区万象南路 

研究负责人通讯地址:

四川省成都市人民南路四段55号 

Applicant address:

South Wanxiang Avenue,High-tech District, Chengdu,Sichuan Province, China 

Study leader's address:

55th, Section 4, Renmin south avenue, Chengdu, Sichuan Province, 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:

江苏恒瑞医药股份有限公司 

Applicant's institution:

Hengrui Medical 

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:

SCCHEC-02-2022-029 

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:

四川省肿瘤医院医学科研与医疗新技术伦理委员会 

Name of the ethic committee:

Ethics Committee for Medical Research and New Medical Technology of Sichuan Cancer Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

李婷媛 

Contact Name of the ethic committee:

Tingyuan Li 

伦理委员会联系地址:

四川省成都市人民南路四段55号 

Contact Address of the ethic committee:

55th, Section 4, Renmin south avenue, Chengdu, Sichuan Province, 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:

四川省肿瘤医院 

Primary sponsor:

Sichuan Cancer Hospital 

研究实施负责(组长)单位地址:

四川省成都市人民南路四段55号 

Primary sponsor's address:

55th, Section 4, Renmin south avenue, Chengdu, Sichuan Province, 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):

四川省

市(区县):

Country:

China

Province:

Sichuan Province

City:

单位(医院):

四川省肿瘤医院

具体地址:

四川省成都市人民南路四段55号

Institution
hospital:

Sichuan Cancer Hospital

Address:

55th, Section 4, Renmin south avenue, Chengdu, Sichuan Province, China

经费或物资来源:

NA 

Source(s) of funding:

NA 

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:

上市后药物 

Study phase:

研究目的:

主要研究目的: 观察卡瑞利珠单抗跨线联合治疗用于一线卡瑞利珠单抗联合含铂双药化疗治疗失败的转移性非小细胞肺癌患者在真实世界中的疗效。 次要研究目的: 1. 观察卡瑞利珠单抗跨线联合治疗用于一线卡瑞利珠单抗联合含铂双药化疗治疗失败的转移性非小细胞肺癌患者在真实世界中的安全性; 2. 观察不同联合用药模式在一线卡瑞利珠单抗联合含铂双药化疗治疗失败的转移性非小细胞肺癌患者中的疗效和安全性。 

Objectives of Study:

Primary objective: To evaluate the efficacy of camrelizumab-based therapy in patients with metastatic NSCLC after failed first-line treatment with camrelizumab plus platinum-containing dual-drug chemotherapy in real world. Secondary objective: 1.To evaluate the safety of camrelizumab-based therapy in patients with metastatic NSCLC after failed first-line treatment with camrelizumab plus platinum-containing dual-drug chemotherapy in real world; 2.To evaluate the efficacy and safety of different combination therapy in patients with metastatic NSCLC after failed first-line treatment with camrelizumab plus platinum-containing dual-drug chemotherapy. 

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. 签署知情同意书,自愿加入本研究; 2. 组织/细胞病理学检测证实为非小细胞肺癌; 3. 组织或血浆基因检测常见的肺癌驱动基因EGFR、ALK突变阴性; 4. 年龄≥18周岁; 5.既往一线治疗为卡瑞利珠单抗联合含铂化疗; 6. 研究者判定患者可以接受卡瑞利珠单抗联合治疗。 

Inclusion criteria

1. Subjects sign written informed consent and voluntarily participate in this study; 2. Subjects diagnosed as non-small cell lung cancer (NSCLC) by histology or cytology; 3. Negative EGFR mutation and ALK fusion gene status tested by histology or plasma; 4. At least 18 years of age; 5. Subjects have previously received first-line camrelizumab and platinum-containing chemotherapy; 6. According to the judgment of the investigator, subjects who can receive camrelizumab-based therapy. 

排除标准:

1. 同时接受了其他免疫药物或疗法治疗的患者; 2. 正在参加其他干预性研究的患者; 3. 同时合并有其他恶性肿瘤的患者; 4. 已证实妊娠、哺乳期女性; 5. 研究者认为患者不适合参加本研究的其他任何情况。 

Exclusion criteria:

1.Subjects who are receiving other immune drugs or immunotherapy; 2.Subjects who are participating in other clinical studies; 3.Subjects with other malignancies; 4.During period of pregnancy or breastfeeding; 5.Not suitable for participation in the opinion of investigators. 

研究实施时间:

Study execute time:

From2022-04-01To 2025-07-01 

征募观察对象时间:

Recruiting time:

From2022-04-01To 2024-04-01 

干预措施:

Interventions:

组别:

1

样本量:

150

Group:

1

Sample size:

干预措施:

卡瑞利珠单抗+化疗±放疗

干预措施代码:

Intervention:

Camrelizumab+ chemotherapy(±radiotherapy)

Intervention code:

组别:

2

样本量:

150

Group:

2

Sample size:

干预措施:

卡瑞利珠单抗+放疗

干预措施代码:

Intervention:

Camrelizumab + radiotherapy

Intervention code:

组别:

3

样本量:

100

Group:

3

Sample size:

干预措施:

卡瑞利珠单抗+抗血管生成治疗

干预措施代码:

Intervention:

Camrelizumab +antiangiogenic drugs

Intervention code:

组别:

4

样本量:

100

Group:

4

Sample size:

干预措施:

卡瑞利珠单抗+化疗+抗血管生成治疗

干预措施代码:

Intervention:

Camrelizumab +chemotherapy+antiangiogenic drugs

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川省 

市(区县):

 

Country:

China 

Province:

Sichuan Province 

City:

 

单位(医院):

四川省肿瘤医院 

单位级别:

三级甲等 

Institution
hospital:

Sichuan Cancer Hospital  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

四川省 

市(区县):

 

Country:

China 

Province:

Sichuan Province 

City:

 

单位(医院):

四川省人民医院 

单位级别:

三级甲等 

Institution
hospital:

Sichuan Provincial People's Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

总生存期

指标类型:

主要指标 

Outcome:

OS

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

无进展生存期

指标类型:

次要指标 

Outcome:

PFS

Type:

Secondary 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:

持续缓解时间

指标类型:

次要指标 

Outcome:

DoR

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

安全性

指标类型:

次要指标 

Outcome:

safety

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:

组织

组织:

Sample Name:

tissue

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

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 18 years
最大 Max age NA 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):

NA

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

NA

盲法:

Blinding:

是否共享原始数据:

IPD sharing

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):

NA

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

NA

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:

EDC

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

EDC

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2022-04-02
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