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紫龙金片维持治疗晚期非小细胞肺癌(气血两虚证)的有效性、安全性和经济性随机、双盲、安慰剂平行对照的多中心临床试验
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注册号:

Registration number:

ChiCTR1900027926 

最近更新日期:

Date of Last Refreshed on:

2019-12-04 

注册时间:

Date of Registration:

2019-12-04 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

紫龙金片维持治疗晚期非小细胞肺癌(气血两虚证)的有效性、安全性和经济性随机、双盲、安慰剂平行对照的多中心临床试验 

Public title:

Efficacy, safety and economy of Zi-Long-Jin tablets in the maintenance of advanced non-small cell lung cancer (qi and blood deficiency syndrome): a multicenter, randomized, double-blind, placebo-controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

紫龙金片维持治疗晚期非小细胞肺癌(气血两虚证)的有效性、安全性和经济性随机、双盲、安慰剂平行对照的多中心临床试验 

Scientific title:

Efficacy, safety and economy of Zi-Long-Jin tablets in the maintenance of advanced non-small cell lung cancer (qi and blood deficiency syndrome): a multicenter, randomized, double-blind, placebo-controlled trial 

研究课题代号(代码):

Study subject ID:

课题编号:2018YFC1707410-03 

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:

ChiMCTR1900002807 

申请注册联系人:

崔浩 

研究负责人:

贾英杰 

Applicant:

Hao Cui 

Study leader:

Yingjie Jia 

申请注册联系人电话:

Applicant telephone:

+86 18301231315 

研究负责人电话:

Study leader's telephone:

+86 13802133132 

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:

cuihao@zyyjypj.cn 

研究负责人电子邮件:

Study leader's E-mail:

jiayingjie1616@sina.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:

北京市朝阳区亚运村慧忠北里105号B段京师科技大厦 

研究负责人通讯地址:

天津市西青区王兰庄昌凌路88号 

Applicant address:

Jingshi Science and Technology Building, Section B, 105 Huizhong Street North, Asian Games Village, Chaoyang District, Beijing, China 

Study leader's address:

88 Changling Road, Wang-Lan-Zhuang, Xiqing District, Tianjin, 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:

北京康派特医药科技开发有限公司 

Applicant's institution:

Beijing kangpai medical technology development 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:

TYLL2019[K]字024 

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:

天津中医药大学第一附属医院医学伦理委员会 

Name of the ethic committee:

Medical ethics committee of The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-11-22 

伦理委员会联系人:

贾景蕴 

Contact Name of the ethic committee:

Yingyun Jia 

伦理委员会联系地址:

天津市西青区王兰庄昌凌路88号 

Contact Address of the ethic committee:

88 Changling Road, Wang-Lan-Zhuang, Xiqing District, Tianjin, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 022-27986258 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

yfyiec@163.com 

研究实施负责(组长)单位:

天津中医药大学第一附属医院 

Primary sponsor:

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

天津市西青区王兰庄昌凌路88号 

Primary sponsor's address:

88 Changling Road, Wang-Lan-Zhuang, Xiqing District, Tianjin, 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):

天津市

市(区县):

Country:

China

Province:

Tianjin

City:

单位(医院):

天津中医药大学第一附属医院

具体地址:

天津市西青区王兰庄昌凌路88号

Institution
hospital:

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Address:

88 Changling Road, Wang-Lan-Zhuang, Xiqing District

经费或物资来源:

天津中新药业集团股份有限公司隆顺榕制药厂 

Source(s) of funding:

Tianjin zhongxin pharmaceutical group co., LTD. Longshunrong pharmaceutical factory 

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:

上市后药物 

Study phase:

研究目的:

(1)评价紫龙金片维持治疗晚期非小细胞肺癌的有效性; (2)评价紫龙金片临床应用的安全性; (3)评价紫龙金片临床应用的经济性。 

Objectives of Study:

(1) to evaluate the efficacy of zilongjin tablet in the maintenance treatment of advanced non-small cell lung cancer; (2) to evaluate the safety of zilongjin tablets in clinical application; (3) to evaluate the economic efficiency of clinical application of zilongjin tablets. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1)病理组织学和/或细胞学诊断的Ⅲb~Ⅳ期非小细胞肺癌患者; 2)入组前符合中医气血两虚证辨证诊断的患者; 3)一线化疗方案治疗≥4个周期后疾病稳定(入组前脑转移患者允许使用全脑放疗至稳定状态),且在化疗结束后30天内患者; 4)至少有1个可测量的病灶(RECIST标准1.1版本); 5)ECOG评分≤2,预计生存3个月以上; 6)入组前由研究者根据CTCAE判定化疗期间发生的不良事件已恢复到1级(脱发除外); 7)年龄18~80岁(包括18岁和80岁); 8)自愿参加试验研究,并已签署知情同意书者。 

Inclusion criteria

1) pathological histology and/or cytology diagnosis IIIb ~ IV non-small cell lung cancer; 2) patients who met the syndrome differentiation diagnosis of qi and blood deficiency syndrome in traditional Chinese medicine before enrollment; 3) the disease was stable after >=4 cycles of first-line chemotherapy (whole-brain radiotherapy was allowed to be used in patients with forebrain metastasis to a stable state), and within 30 days after the end of chemotherapy; 4) at least 1 measurable lesion (RECIST standard version 1.1); 5) ECOG score <=2, expected to survive for more than 3 months; 6) before enrollment, the adverse events occurred during chemotherapy were determined by the researcher according to CTCAE to have recovered to level 1 (except hair loss); 7) Aged 18 ~ 80 years old; 8) those who voluntarily participate in the study and have signed the informed consent. 

排除标准:

1)未受控制的脑转移患者。 2)入组前有明确靶向治疗基因检测结果阳性(EGFR阳性或ALK阳性或ROS1阳性或PD-L1≥50%)的患者。 3)实验室检查符合以下任何一项:白细胞<3.0×109/L,中性粒细胞<1.5×109/L,血小板<6×1010/L,红细胞<2×1012/L,血红蛋白<8.0g/dl,ALT、AST或Scr超过正常上限2倍,血胆红素超过正常值上限1.5倍者。 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)有严重出血倾向或出血性疾病的患者。 6)5年内或目前患有其他原发性恶性肿瘤的患者。 7)精神疾病患者,药物滥用或酗酒者。 8)妊娠期,哺乳期或有妊娠可能以及计划妊娠的患者。 9)过敏体质或对本药品过敏者。 10)既往3个月内参加过或正在参加其他临床试验者。 11)研究者认为存在其他任何不适合入选情况者。 

Exclusion criteria:

1) uncontrolled brain metastases; 2) patients with positive gene test results of specific targeted therapy (EGFR positive or ALK positive or ROS1 positive or pd-l1 >=50%) before enrollment; 3) the laboratory examination met any of the following criteria: white blood cells < 3.0x10^9/L, neutrophils < 1.5x10^9/L, platelets < 6x10^10/L, red blood cells < 2x10^12/L, hemoglobin < 8.0g/dl, ALT, AST or Scr exceeding 2 times the normal upper limit, and blood bilirubin exceeding 1.5 times the normal upper limit; 4) patients with severe and uncontrolled organic disease or infection, such as decompensated heart, lung and renal failure, which lead to intolerance of chemotherapy; 5) patients with severe bleeding tendency or bleeding disease; 6) patients with other primary malignancies within 5 years or currently; 7) mental illness, drug or alcohol abuse; 8) patients during pregnancy, lactation or pregnancy possibility or planned pregnancy; 9) allergy or allergy to this medicine; 10) have participated in or are participating in other clinical trials within the previous 3 months; 11) the researcher believes that there are any other ineligible conditions. 

研究实施时间:

Study execute time:

From2019-08-01To 2021-10-30 

征募观察对象时间:

Recruiting time:

From2019-12-01To 2020-12-01 

干预措施:

Interventions:

组别:

试验组

样本量:

120

Group:

experimental group

Sample size:

干预措施:

紫龙金片+基础治疗

干预措施代码:

Intervention:

Zi-long-jin tablet+basic treatment

Intervention code:

组别:

对照组

样本量:

120

Group:

control group

Sample size:

干预措施:

紫龙金片模拟剂+基础治疗

干预措施代码:

Intervention:

Zi-long-jin tablet simulant + basic treatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京大学肿瘤医院 

单位级别:

三甲 

Institution
hospital:

Beijing University tumor hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京中医药大学第三附属医院 

单位级别:

三甲 

Institution
hospital:

The third affiliated hospital of Beijing university of Chinese medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海市肺科医院 

单位级别:

三甲 

Institution
hospital:

Shanghai Pulmonary Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海中医药大学附属岳阳中西医结合医院 

单位级别:

三甲 

Institution
hospital:

Yueyang integrated traditional Chinese and western medicine hospital affiliated to Shanghai university of traditional Chinese medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

广州医科大学附属肿瘤医院 

单位级别:

三甲 

Institution
hospital:

Affiliated tumor hospital of guangzhou medical university  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

新疆维吾尔自治区 

市(区县):

 

Country:

China 

Province:

Xinjiang Uygur Autonomous Region 

City:

 

单位(医院):

新疆维吾尔自治区中医医院 

单位级别:

三甲 

Institution
hospital:

Xinjiang uygur autonomous region hospital of traditional Chinese medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

重庆 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

重庆市中医院 

单位级别:

三甲 

Institution
hospital:

Chongqing Traditional Chinese Medicine Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

重庆 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

重庆市肿瘤医院 

单位级别:

三甲 

Institution
hospital:

Chongqing Cancer Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

武汉市第一医院 

单位级别:

三甲 

Institution
hospital:

Wuhan first 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):

浙江省肿瘤医院 

单位级别:

三甲 

Institution
hospital:

Zhejiang Cancer Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

山西 

市(区县):

 

Country:

China 

Province:

Shanxi 

City:

 

单位(医院):

山西省肿瘤医院 

单位级别:

三甲 

Institution
hospital:

Shanxi cancer hospital  

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:

三甲 

Institution
hospital:

Liaoning Cancer Hospital and Institute  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

南方医科大学中西医结合医院 

单位级别:

三甲 

Institution
hospital:

Hospital of integrated traditional Chinese and western medicine, southern medical university  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津市肿瘤医院 

单位级别:

三甲 

Institution
hospital:

Tianjin tumor hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

陕西 

市(区县):

 

Country:

China 

Province:

Shaanxi 

City:

 

单位(医院):

陕西省肿瘤医院 

单位级别:

三甲 

Institution
hospital:

Shanxi Provincial Tumor Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

河北 

市(区县):

 

Country:

China 

Province:

Hebei 

City:

 

单位(医院):

秦皇岛市中医院 

单位级别:

三甲 

Institution
hospital:

Qinhuangdao hospital of traditional Chinese medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

陕西 

市(区县):

 

Country:

China 

Province:

Shaanxi 

City:

 

单位(医院):

西京医院 

单位级别:

三甲 

Institution
hospital:

Xijing Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

无进展生存期(PFS)

指标类型:

主要指标 

Outcome:

Progression-free survival (PFS)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺癌相关的生活质量量表(FACT-L)评分

指标类型:

主要指标 

Outcome:

Lung cancer - related quality of life scale (fact-l) score

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疾病进展时间(TTP)

指标类型:

次要指标 

Outcome:

Time of disease progression (TTP)

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(ORR)

指标类型:

次要指标 

Outcome:

Objective response rate (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(DCR)

指标类型:

次要指标 

Outcome:

Disease control rate (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:

中医证候积分

指标类型:

次要指标 

Outcome:

TCM syndrome score

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:

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:

大便

组织:

Sample Name:

bowels

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 80 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):

中央随机

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

The random

盲法:

双盲

Blinding:

Double 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):

试验完成后公开

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

Within six months after the tril 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:

电子采集和管理系统

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

Electronic Data Capture, EDC

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2019-12-04
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