今天是:2019-08-22 星期四

晚期非鳞非小细胞肺癌患者二线及以上治疗中应用安罗替尼联合多西他赛的疗效及安全性临床研究
下载XML文档

注册号:

Registration number:

ChiCTR1900023186 

最近更新日期:

Date of Last Refreshed on:

2019-05-15 

注册时间:

Date of Registration:

2019-05-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

晚期非鳞非小细胞肺癌患者二线及以上治疗中应用安罗替尼联合多西他赛的疗效及安全性临床研究 

Public title:

Clinical Study for the Efficacy and Safety of Anlotinib Combined with Docetaxel in the Second Line and above Treatment of Advanced Non-squamous Non-small Cell Lung Cancer 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

晚期非鳞非小细胞肺癌患者二线及以上治疗中应用安罗替尼联合多西他赛的疗效及安全性临床研究 

Scientific title:

Clinical Study for the Efficacy and Safety of Anlotinib Combined with Docetaxel in the Second Line and above Treatment of Advanced Non-squamous Non-small Cell Lung Cancer 

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:

张帆 

研究负责人:

魏素菊 

Applicant:

ZhangFan 

Study leader:

Wei Suju 

申请注册联系人电话:

Applicant telephone:

+86 18531117235 

研究负责人电话:

Study leader's telephone:

+86 13933856918 

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:

zflzlk@163.com 

研究负责人电子邮件:

Study leader's E-mail:

weisuju@126.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:

河北省石家庄市健康路12号 

研究负责人通讯地址:

河北省石家庄市长安区健康路12号 

Applicant address:

12 Jiankang Road, Shijiazhuang, China 

Study leader's address:

12 Jiankang Road, Shijiazhuang, 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:

河北医科大学第四医院肿瘤内科 

Applicant's institution:

Oncology Department, The Fourth Hospital of Hebei 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:

2019028 

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:

河北医科大学第四医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of the Fourth Hospital of Hebei Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-04-28 

伦理委员会联系人:

张俊敏 

Contact Name of the ethic committee:

Zhang Junmin 

伦理委员会联系地址:

河北省石家庄市健康路12号 

Contact Address of the ethic committee:

12 Jiankang Road, Shijiazhuang, 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:

河北医科大学第四医院 

Primary sponsor:

The Fourth Hospital of Hebei Medical University 

研究实施负责(组长)单位地址:

河北省石家庄市健康路12号 

Primary sponsor's address:

12 Jiankang Road, Shijiazhuang, 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):

河北省

市(区县):

石家庄市

Country:

China

Province:

Hebei

City:

Shijiazhuang

单位(医院):

河北医科大学第四医院

具体地址:

健康路12号

Institution
hospital:

The Fourth Hospital of Hebei Medical University

Address:

12 Jiankang Road

经费或物资来源:

研究者自主 

Source(s) of funding:

The fund raised by investigator 

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:

探索安罗替尼联合多西他赛用于晚期非鳞非小细胞肺癌患者二线及以上治疗的有效性及安全性。 

Objectives of Study:

To explore the efficacy and safety of combination of amlotinib and docetaxel in second-line or above treatment of advanced non-squamous non-small cell lung cancer. 

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18-75岁,依从性良好。 2、经组织学/细胞学诊断为非鳞非小细胞肺癌。 3、在过去3个月内至少存在1处尚未接受放疗的靶病灶,具有RECIST1.1定义的可测量病灶。 4、接受过≥1线治疗(包括化疗及EGFR-TKI)失败或无法耐受治疗的患者。 5、ECOG评分0-2,预计生存期≥3个月。 6、无严重出血倾向,无急性感染,无明显肝、肾和心脏功能不全。 7、育龄妇女必须已经采取可靠的避孕措施或在入组前7天内进行妊娠试验(血清或尿液),且结果为阴性。 8、患者自愿参加研究,签署知情同意书。 

Inclusion criteria

1. Aged 18-75 years, with good compliance. 2. Histological/cytological diagnosis as non-squamous non-small cell lung cancer. 3. At least one target lesion has not been treated by radiotherapy with RECIST 1.1 definition and measurable lesion in the past three months. 4. Patients who have failed or cannot tolerate greater than or equal to one treatment,including chemotherapy and EGFR-TKI. 5. ECOG 0-2, estimated survival time more than 3 months. 6. With no severe bleeding tendency, no acute infection, no obvious liver, kidney or heart dysfunction. 7. Women of reproductive age must have taken reliable contraceptive measures or conducted pregnancy tests (serum or urine) within 7 days before admission, with negative results. 8. Patients volunteer to participate in the study and sign informed consent. 

排除标准:

1、伴咯血(>20ml/日)的非小细胞肺癌。 2、脑转移有症状或症状控制时间<2个月的患者。 3、存在任何出血体质迹象或病史的患者。 4、影像学显示肿瘤已侵犯重要血管周或经研究者判断在后续治疗期间肿瘤极有可能侵袭重要血管而引起致命大出血者。 5、6个月内发生过动静脉血栓事件,如脑血管意外、深静脉血栓及肺栓塞者。 6、严重的不可控的心脑血管及其他重要脏器疾病,如不可控的高血压、进展中的脑卒中、糖尿病、肝肾功能衰竭等。 7、吸毒等不良药瘾、长期嗜酒、以及HIV感染。 8、研究者认为不宜参加本临床研究的实验者。 

Exclusion criteria:

1. Non-small cell lung cancer patients with hemoptysis (>20ml/day). 2. Patients with brain metastasis with symptoms or symptoms control time less than 2 months. 3. Patients with any physical signs or history of bleeding. 4. Imaging findings show that tumors have invaded important perivascular areas or that during subsequent treatment, tumors are highly likely to invade important blood vessels and cause fatal hemorrhage. 5. Arteriovenous thrombosis occurred within 6 months, such as cerebrovascular accident, deep venous thrombosis and pulmonary embolism. 6. Severe uncontrollable cardiovascular and cerebrovascular diseases and other important organ diseases, such as uncontrollable hypertension, progressive stroke, diabetes, liver and kidney failure, etc. 7. Drug addiction, chronic alcoholism, and HIV infection. 8. Researchers consider inappropriate to participate in this clinical study. 

研究实施时间:

Study execute time:

From2019-05-20To 2020-12-31 

干预措施:

Interventions:

组别:

single arm

样本量:

15

Group:

single arm

Sample size:

干预措施:

安罗替尼联合多西他赛

干预措施代码:

Intervention:

combination of amlotinib and docetaxel

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

河北省 

市(区县):

石家庄市 

Country:

China 

Province:

Hebei 

City:

Shijiazhuang 

单位(医院):

河北医科大学第四医院 

单位级别:

三甲医院 

Institution
hospital:

The Fourth Hospital of Hebei Medical University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

近期(3月内)客观缓解率

指标类型:

主要指标 

Outcome:

ORR within 3 months

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:

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:

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:

不良反应

指标类型:

副作用指标 

Outcome:

AE

Type:

Adverse events 

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:

标本中文名:

尿液

组织:

Sample Name:

urine

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:

粪便

组织:

Sample Name:

Faeces

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 18 years
最大 Max age 75 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):

不适用,单臂试验

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

N/A. This is a single arm study.

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

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):

通过期刊杂志发表

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

Published through journals and magazines.

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:

CRF

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-05-15
返回列表