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复方苦参注射液联合单药化疗治疗老年晚期NSCLC患者的随机对照多中心临床研究
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注册号:

Registration number:

ChiCTR-IPR-14005484 

最近更新日期:

Date of Last Refreshed on:

2014-11-16 

注册时间:

Date of Registration:

2014-10-16 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

复方苦参注射液联合单药化疗治疗老年晚期NSCLC患者的随机对照多中心临床研究 

Public title:

A randomized controlled multicenter clinical study of compound Kushen Injection combined with single-agent chemotherapy in elderly patients of advanced NSCLC 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

复方苦参注射液治疗恶性肿瘤的上市后再评价研究 

Scientific title:

Post-marketing Clinical Research on compound Kushen Injection in Treatment of Malignant Neoplasm 

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:

吕建平 

研究负责人:

林洪生 

Applicant:

Jianping Lv 

Study leader:

Hongsheng Lin 

申请注册联系人电话:

Applicant telephone:

+86 18301540967 

研究负责人电话:

Study leader's telephone:

+86 13718716339 

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:

lvjianping8282@126.com 

研究负责人电子邮件:

Study leader's E-mail:

dr.liujie@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:

北京市宣武区广安门内大街200号东华金座西塔楼501室 

研究负责人通讯地址:

中国中医科学院广安门医院 

Applicant address:

Room501, the west tower of Donghuajinzuo Building, #200, Guang'anmennei Street, Xuanwu District, Beijing 

Study leader's address:

Guang'anmen Hospital affiliatied to China Academy of Chinese Medical Sciences 

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:

北京正聚医药科技有限公司 

Applicant's institution:

Beijing Zheng Ju Medical Technology Co.,Ltd. 

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:

2014EC086-01 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

中国中医科学院广安门医院伦理委员会 

Name of the ethic committee:

The Ethic Committee of Guang'anmen Hospital , China Academy of Chinese Medical Sciences 

伦理委员会批准日期:

Date of approved by ethic committee:

2014-10-24 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

中国中医科学院广安门医院 

Primary sponsor:

Guang'anmen Hospital, China Academy of Chinese Medical Sciences 

研究实施负责(组长)单位地址:

北京市宣武区北线阁5号 

Primary sponsor's address:

No. 5 Bei Xian Ge St. Xuan Wu District, Beijing, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

山西振东制药股份有限公司 

Source(s) of funding:

Shanxi Zhendong pharmaceutical co., LTD 

研究疾病:

非小细胞肺癌 

Target disease:

Non-small cell lung cancer 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

IV期临床试验 

Study phase:

研究目的:

评价复方苦参注射液联合单药化疗治疗老年晚期NSCLC的有效性和安全性 

Objectives of Study:

Evaluation the efficiency and safety of compound Kushen Injection combined with single drug of the chemotherapy in the elderly advanced NSCLC treatment. 

药物成份或治疗方案详述:

苦参、白士苓 

Description for medicine or protocol of treatment in detail:

Sophora Flavescens、Heterosmilacis Japonicae 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

(1)在任何研究相关程序开始前获得患者签署的知情同意书。患者对本研究已充分了解并自愿签署书面知情同意书; (2)年龄60~75岁,性别不限; (3)经病理学确诊的Ⅲ~Ⅳ期NSCLC患者; (4)根据RECIST(第1.1版),至少具有一个未经局部治疗的可测量病灶,螺旋CT或核磁共振(MRI),病灶最大直径≥10mm(恶性淋巴结CT扫描短径≥15 mm); (5)东部肿瘤协调组(ECOG)一般状况评分≤2分; (6)各器官功能基本正常(在无持续支持治疗的情况下,入组前1周之内的实验室检查结果):白细胞>3.0×109/L;中性粒细胞>1.5×109/L;血小板>,60×109/L;血红蛋白>8.0g/dl;胆红素 正常或<1.5×ULN;AST(SGOT)、ALT(SGPT) < 2.0×ULN );血清肌酐<1.5×ULN; (7)预计生存期≥3个月。 

Inclusion criteria

(1) Before the start of the study, All patients have been fully understood and the willingness to sign the informed consent; (2) Aged from 60 to 75 years old,Sex unlimited; (3) III-IV stage NSCLC must be diagnosis by pathology; (4) According to RECIST, At least 1 Measurable lesions without local treatment, Spiral CT or MRI, maximum diameter larger than at least 10mm (Malignant lymph nodes on CT scans short diameter larger than at least 15mm); (5) Eastern Cooperative Oncology Group (ECOG) performance status less than at least 2; (6) The basic normal organ function, WBC more than 3.0*10^9/L; NEUT# more than 1.5*10^9/L; PLT more than 60*10^9/L; HGB more than 8.0g/dl; BIL at normal level or less than 1.5*ULN; AST(SGOT), ALT(SGPT) less than 2.0*ULN); SCr less than 1.5*ULN; (7) Expected survival time must more than 3 months. 

排除标准:

(1)2周内曾接受过复方苦参注射液治疗的患者; (2)妊娠或哺乳期女性或有妊娠可能的女性首次用药前妊娠检测阳性; (3)仅有不可测量的病灶如胸水、肺癌性淋巴管炎、腹水、腹膜癌性病变,弥漫性肝侵犯,骨转移; (4)有严重、未控制的器质性病变或感染,如失代偿的心、肺、肾功能衰竭等导致不能耐受化疗的患者; (5)正在参加或最近30天内参加过另一项临床研究; (6)对本试验药物过敏者; (7)既往有严重的心理或精神异常、药物成瘾或酒精依赖者; 估计患者参加本临床研究的依从性不足。 

Exclusion criteria:

(1) Ever received compound Kushen therapy within 2 weeks; (2) Pregnancy or lactation women; (3) Only with immeasurable lesions such as pleural effusion,pulmonary lymphangitic carcinomatosis, ascites, peritoneal cancer lesions, diffuse hepatic involvement, bone metastasis; (4) Patients with severe, uncontrolled organic lesions or infection, such as decompensated heart, lung, kidney failure can lead to tolerance of chemotherapy; (5) participating in another clinical study or have participated in another clinical study within 30 days; (6) Aallergic to the testing compound. 

研究实施时间:

Study execute time:

From2014-10-25To  

征募观察对象时间:

Recruiting time:

From2014-10-25To  

干预措施:

Interventions:

组别:

A

样本量:

90

Group:

A

Sample size:

干预措施:

含铂两药联合化疗

干预措施代码:

Intervention:

Platinum-based two bites MDT

Intervention code:

组别:

B

样本量:

90

Group:

B

Sample size:

干预措施:

单药化疗+复方苦参注射液

干预措施代码:

Intervention:

Single-acemotherapy combined compound Kuhshen Injectiongent

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

山西 

市(区县):

 

Country:

China 

Province:

Shanxi 

City:

 

单位(医院):

山西省中医院 

单位级别:

三级甲等 

Institution
hospital:

Shanxi traditional Chinese  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

辽宁 

市(区县):

 

Country:

China 

Province:

Liaoning 

City:

 

单位(医院):

辽宁省肿瘤医院 

单位级别:

三级甲等 

Institution
hospital:

LiaoningCancer Hospital and Institute  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

安徽 

市(区县):

 

Country:

China 

Province:

Anhui 

City:

 

单位(医院):

安徽省立医院 

单位级别:

三级甲等 

Institution
hospital:

Anhui Provincial Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

浙江省立同德医院 

单位级别:

三级甲等 

Institution
hospital:

Zhejiang tongde hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

浙江省中医院 

单位级别:

三级甲等 

Institution
hospital:

Chinese medicine hospital of Zhejiang province  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

疾病控制率

指标类型:

主要指标 

Outcome:

Disease control rates

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:

主要指标 

Outcome:

Objective response rate

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:

主要指标 

Outcome:

Progression-free surial

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:

生活质量

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:

临床症状

指标类型:

次要指标 

Outcome:

Clinical Symptoms

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肿瘤标志物

指标类型:

次要指标 

Outcome:

Tumor markers

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体重

指标类型:

次要指标 

Outcome:

weight

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:

次要指标 

Outcome:

Adverse reactions

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

ECOG PS

指标类型:

次要指标 

Outcome:

ECOG PS

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:

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 60 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):

SAS Software

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

SAS Software

盲法:

Blinding:

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:

即时公开/Real time access

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):

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

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:

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

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2014-10-16
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