今天是:2019-06-18 星期二

支气管动脉微球栓塞联合阿帕替尼治疗中央型肺鳞癌的安全性和有效性研究
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注册号:

Registration number:

ChiCTR1900023806 

最近更新日期:

Date of Last Refreshed on:

2019-06-12 

注册时间:

Date of Registration:

2019-06-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

支气管动脉微球栓塞联合阿帕替尼治疗中央型肺鳞癌的安全性和有效性研究 

Public title:

Study on the safety and efficacy of bronchial artery microsphere embolization combined with apatinib in the treatment of central pulmonary squamous cell carcinoma 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

支气管动脉微球栓塞联合阿帕替尼治疗中央型肺鳞癌的安全性和有效性研究 

Scientific title:

Study on the safety and efficacy of bronchial artery microsphere embolization combined with apatinib in the treatment of central pulmonary squamous cell carcinoma 

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:

朱军 

研究负责人:

朱军 

Applicant:

Zhu Jun 

Study leader:

Zhu Jun 

申请注册联系人电话:

Applicant telephone:

+86 13890960428 

研究负责人电话:

Study leader's telephone:

+86 13890960428 

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:

865149749@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

865149749@qq.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:

四川省宜宾市北大街96号 

研究负责人通讯地址:

四川省宜宾市北大街96号 

Applicant address:

96 North Street, Yibin, Sichuan, China 

Study leader's address:

96 North Street, Yibin, Sichuan, 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:

宜宾市第二人民医院 

Applicant's institution:

The Second People's Hospital of Yibin  

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:

2019-032-01 

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:

宜宾市第二人民医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of the second People's Hospital of Yibin 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-06-06 

伦理委员会联系人:

曾梅 

Contact Name of the ethic committee:

Zeng Mei 

伦理委员会联系地址:

四川省宜宾市北大街96号 

Contact Address of the ethic committee:

96 North Street, Yibin, Sichuan, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 13890966307 

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:

宜宾市第二人民医院 

Primary sponsor:

The Second People's Hospital of Yibin  

研究实施负责(组长)单位地址:

四川省宜宾市北大街96号 

Primary sponsor's address:

96 North Street, Yibin, Sichuan, 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

市(区县):

宜宾

Country:

China

Province:

Sichuan

City:

Yibin

单位(医院):

宜宾市第二人民医院

具体地址:

北大街96号

Institution
hospital:

The Second People's Hospital of Yibin

Address:

96 North Street

经费或物资来源:

中国健康促进基金会肿瘤介入科研基金 

Source(s) of funding:

Cancer intervention research fund of China health promotion foudation  

研究疾病:

中央型肺鳞癌 

Target disease:

central pulmonary squamous cell carcinoma 

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:

探索性研究/预试验 

Study phase:

研究目的:

评价支气管动脉微球栓塞联合阿帕替尼治疗一线化疗失败的晚期中央型肺鳞癌的安全性和有效性。 

Objectives of Study:

To evaluate the safety and efficacy of bronchial artery microsphere embolization combined with apatinib in the treatment of advanced central lung squamous cell carcinoma with first-line chemotherapy failure. 

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:

经病理学证实的肺鳞癌;影像学提示为中央型肺癌,至少有一处可测量病灶(按照 RECIST1.1 标准进行评价);无外科手术机会,临床分期ⅢB或Ⅳ期;ECOG评分0-2分;预计生存期≥3月;患者既往接受过含铂类为主双药联合的一线化疗方案,影像学评价治疗无效或病变进展;实验室常规检查(血常规、肝肾功能、凝血功能等)无显著异常;受试者自愿加入本研究,并签署知情同意书,依从性好,配合随访。 

Inclusion criteria

Pathologically confirmed squamous cell carcinoma of the lung; Imaging showed central lung cancer with at least one measurable lesion (RECIST1.1). No surgery opportunity, clinical stage IV or III B; ECOG score is 0-2; Expected survival ≥3 months; The patient had previously received the first-line chemotherapy regimen with platinum-containing drugs combined with two drugs, and was failure or lesion progression by imaging evaluation; Routine laboratory examination (blood routine, liver and kidney function, coagulation function, etc.) was not significant abnormal. Subjects volunteered to participate in this study and signed informed consent, with good compliance and follow-up. 

排除标准:

有相关手术病史或放疗病史;药物不能控制的顽固性高血压;脑转移;严重凝血功能异常;严重心肺功能障碍或无法平卧患者;入组前使用过其他抗血管生成药(如恩度、贝伐单抗等);怀孕或哺乳期妇女;有生育能力的患者不愿或无法采取有效的避孕措施者;有阿帕替尼说明书规定的禁忌症者;正参加其它临床试验的患者;研究过程中失访、介入栓塞不成功患者;医学影像学检查显示病情进展,研究者认为不适宜继续服用阿帕替尼;NCI-CTC分级3级及以上出血或其他毒副作用,经剂量调整、对症处理,受试者仍然无法耐受者 

Exclusion criteria:

A history of surgery or radiation therapy; Intractable hypertension beyond the control of drugs;Brain metastasis; Severe abnormal coagulation function; Patients with severe cardiopulmonary dysfunction or inability to lie flat; Other antiangiogenic agents (such as endor, bevacizumab, etc.) were used before enrollment.Pregnant or lactating women;Patients with fertility are unwilling or unable to take effective contraceptive measures; Contraindications specified in the instructions for apatinib; Patients are participating in other clinical trials; During the study, the patients were lost to follow-up and the interventional embolization was unsuccessful. Medical imaging examination showed the progress of the disease, and the researchers considered it inappropriate to continue taking apatinib. Patients with NCI-CTC grade 3 or above, bleeding or other toxic side effects, cannot be tolerated after dose adjustment and symptomatic treatment. 

研究实施时间:

Study execute time:

From2019-06-01To 2021-06-30 

干预措施:

Interventions:

组别:

系列病例

样本量:

38

Group:

case series

Sample size:

干预措施:

支气管动脉微球栓塞联合阿帕替尼

干预措施代码:

Intervention:

bronchial artery microsphere embolization combined with apatinib

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

宜宾 

Country:

China 

Province:

Sichuan 

City:

Yibin 

单位(医院):

宜宾市第二人民医院 

单位级别:

三甲 

Institution
hospital:

The Second People's Hospital of Yibin  

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:

progression free survival

Type:

Primary 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:

overall survival

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:

objective response rate

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:

Disease control rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生活质量评估

指标类型:

次要指标 

Outcome:

quality of life

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

咯血

指标类型:

次要指标 

Outcome:

hemoptysis

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

实验室检测值异常率

指标类型:

次要指标 

Outcome:

abnormal rate of laboratory test

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

不良事件及严重不良事件的发生率

指标类型:

次要指标 

Outcome:

Incidence of adverse events and serious adverse events

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:

正在进行

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):

未使用

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

Not used

盲法:

N/A

Blinding:

N/A

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

预计试验完成后6个月

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

IPD will be public accessable six months after trial complete

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:

病例报告表

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

Case Record Form

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-06-12
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