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A multi-center randomized controlled trial of Liu Jiaxiang Qi-Yin Recipe for improving the prognosis of patients with stage IIIA non-small cell lung cancer after radical resection
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注册号:

Registration number:

ChiCTR2000029456 

最近更新日期:

Date of Last Refreshed on:

2020-02-02 

注册时间:

Date of Registration:

2020-02-02 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

刘嘉湘气阴辨治方药改善IIIA期非小细胞肺癌根治术后患者预后的多中心随机对照研究 

Public title:

A multi-center randomized controlled trial of Liu Jiaxiang Qi-Yin Recipe for improving the prognosis of patients with stage IIIA non-small cell lung cancer after radical resection 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

刘嘉湘气阴辨治方药改善IIIA期非小细胞肺癌根治术后患者预后的多中心随机对照研究 

Scientific title:

A multi-center randomized controlled trial of Liu Jiaxiang Qi-Yin Recipe for improving the prognosis of patients with stage IIIA non-small cell lung cancer after radical resection 

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:

ChiMCTR2000002957 

申请注册联系人:

毕向雁 

研究负责人:

刘苓霜 

Applicant:

Xiangyan Bi 

Study leader:

Lingshuang Liu 

申请注册联系人电话:

Applicant telephone:

+86 18317067515 

研究负责人电话:

Study leader's telephone:

+86 13818510253 

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:

384901602@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

liuls107@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:

上海徐汇区宛平南路725号上海中医药大学附属龙华医院肿瘤科  

研究负责人通讯地址:

上海徐汇区宛平南路725号 

Applicant address:

725 South Wanping Road, Xuhui District, Shanghai, China  

Study leader's address:

725 South Wanping Road, Xuhui District, Shanghai, China 

申请注册联系人邮政编码:

Applicant postcode:

200032 

研究负责人邮政编码:

Study leader's postcode:

200032 

申请人所在单位:

上海中医药大学附属龙华医院 

Applicant's institution:

Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine  

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:

19401971200 

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:

上海中医药大学附属龙华医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine.  

伦理委员会批准日期:

Date of approved by ethic committee:

2019-12-26 

伦理委员会联系人:

刘胜 

Contact Name of the ethic committee:

Sheng Liu 

伦理委员会联系地址:

上海徐汇区宛平南路725号 

Contact Address of the ethic committee:

725 South Wanping Road, Xuhui District, Shanghai, 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:

上海中医药大学附属龙华医院 

Primary sponsor:

Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine  

研究实施负责(组长)单位地址:

上海徐汇区宛平南路725号上海中医药大学附属龙华医院肿瘤科  

Primary sponsor's address:

725 South Wanping Road, Xuhui District, Shanghai, 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):

上海

市(区县):

徐汇区

Country:

China

Province:

Shanghai

City:

单位(医院):

上海中医药大学附属龙华医院

具体地址:

上海徐汇区宛平南路725号

Institution
hospital:

Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine.

Address:

725 South Wanping Road, Xuhui District

经费或物资来源:

上海市科学技术委员会 

Source(s) of funding:

Shanghai Science and Technology Committee  

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:

观察刘嘉湘气阴辨治法延缓ⅢA期NSCLC 根治术后复发转移及改善生活质量的临床疗效,建立疗效确切的规范化方案,为国医大师刘嘉湘教授“扶正治癌”学术经验的传承和推广应用提供循证依据。  

Objectives of Study:

Observe Liu Jiaxiang's Qi-yin differentiation treatment delays the clinical effect of recurrence and metastasis of NSCLC at stage IIIA and improves the quality of life. Establish a standardized program with exact curative effect, and provide a guide for the inheritance and popularization of the academic experience of Professor Liu Jiaxiang, who is helping to cure cancer. Evidence basis. 

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接受根治术的ⅢA 期患者,术后病理学证实为NSCLC。 ②完成术后 4周期辅助化疗(ⅢA-N2 患者可以接受术后辅助放疗)后1个月内,且未出现复发或转移。 ③术后辅助化(放)疗期间未接受中医药治疗。 ④中医辨证为气虚、阴虚或气阴两虚型。 ⑤年龄在 18 岁-75 岁之间(含 18、75 岁)。 ⑥体力状况评分(ECOG PS)≤3 分。 ⑦血常规、肝肾功能基本正常者。 ⑧患者依从性好,能理解本研究的情况并签署知情同意书。 

Inclusion criteria

1. In stage IIIA patients undergoing radical surgery, postoperative pathology confirmed NSCLC; 2. Within 1 month after completion of 4 cycles of adjuvant chemotherapy (IIIA-N2 patients can receive adjuvant radiotherapy), no recurrence or metastasis occurred; 3. During the postoperative adjuvant (radiation) treatment, no Chinese medicine was received; 4. TCM syndrome differentiation is Qi deficiency, Yin deficiency or Qi deficiency; 5. Aged between 18 and 75 years old; 6. Physical performance score (ECOG PS) <=3 points. 7. Blood routine, liver and kidney function were normal. 8. Patients have good compliance, can understand the situation of this study and sign informed consent. 

排除标准:

①预期生存期<6 个月者。 ②无明确病理诊断者。 ③患者合并有心、肝、肾和造血系统等严重疾病。 ④妊娠或哺乳期患者。 ⑤患有不易控制的精神病史者。 

Exclusion criteria:

1. The expected survival time is less than 6 months; 2. No clear pathological diagnosis; 3. The patient had severe diseases such as heart, liver, kidney and hematopoietic system; 4. pregnant or lactating patients; 5. People with a history of mental illness that is difficult to control. 

研究实施时间:

Study execute time:

From2011-02-07To 2022-06-30 

征募观察对象时间:

Recruiting time:

From2020-02-07To 2022-03-01 

干预措施:

Interventions:

组别:

治疗组

样本量:

54

Group:

Experimental group

Sample size:

干预措施:

气阴辨证浓缩颗粒剂

干预措施代码:

Intervention:

Qi-Yin concentration granules

Intervention code:

组别:

对照组

样本量:

54

Group:

Control group

Sample size:

干预措施:

Conventional treatment

干预措施代码:

Intervention:

Conventional treatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

徐汇区 

Country:

China 

Province:

Shanghai 

City:

Xuhui distirct 

单位(医院):

上海中医药大学附属龙华医院 

单位级别:

三甲医院 

Institution
hospital:

Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine.  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

杨浦区 

Country:

China 

Province:

Shanghai 

City:

Yangpu distirct 

单位(医院):

同济大学附属上海市肺科医院 

单位级别:

三甲医院 

Institution
hospital:

Shanghai Pulmonary Hospital affiliated to Tongji University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

徐汇区 

Country:

China 

Province:

Shanghai 

City:

Xuhui district 

单位(医院):

上海市胸科医院 

单位级别:

三甲医院 

Institution
hospital:

Shanghai Chest Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

徐汇区 

Country:

China 

Province:

Shanghai 

City:

Xuhui district 

单位(医院):

上海市肿瘤医院 

单位级别:

三甲医院 

Institution
hospital:

Shanghai Cancer Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

无病生存期

指标类型:

主要指标 

Outcome:

Disease-free survival, DFS

Type:

Primary indicator 

测量时间点:

测量方法:

观察是否有复发转移,是否生存

Measure time point of outcome:

Measure method:

Observe recurrence, metastasis, and survival condition

指标中文名:

2年无病生存率

指标类型:

次要指标 

Outcome:

2-year disease-free survival 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:

生活质量评价

指标类型:

次要指标 

Outcome:

Quality of life

Type:

Secondary indicator 

测量时间点:

每个周期

测量方法:

EORTC QLQ-C30和QLQ-LC13生存质量量表

Measure time point of outcome:

Every period of treatment

Measure method:

the European Organizationfor Research and Treatment of Cancer quality-of-life question-naire QLQ-C30 (EORTC QLQ-C30, Chinese version 3.0) and EORTCQLQ-LC13 (Chinese version)

指标中文名:

中医症状评定标准

指标类型:

次要指标 

Outcome:

symptoms lists questionnaire otraditional Chinese medicine

Type:

Secondary indicator 

测量时间点:

每个周期

测量方法:

原发性肺癌症状分级量化表

Measure time point of outcome:

Every period of treatment

Measure method:

Primary lung cancer symptom classifying quantization tables

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:

是否生存

Measure time point of outcome:

Measure method:

Observe survival condition

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 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):

各中心招募的研究对象在上海中医药大学附属龙华医院进行基本信息采集,经纳排标准筛查后,确定入组对象后,进行分层随机,分层因素为中医证型(气虚证、阴虚证、气阴两虚证)及ⅢA-N2(N2 与非 N2),产生并保存随机号。

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

The research subjects recruited by each center collected basic information at Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine. After screening for admission criteria, they were randomized after stratification. Deficiency syndrome, Qi and Yin deficiency syndrome) and ⅢA-N2 (N2 and non-N2), gen

盲法:

Open label

Blinding:

Open label

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

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):

2022.06

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

2022.06

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:

CRF

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:

无/No

注册人:

Name of Registration:

 2020-02-02
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