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扶正抗癌方联合吉非替尼治疗EGFR基因突变晚期非小细胞肺癌的多中心、随机、双盲、安慰剂对照研究
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注册号:

Registration number:

ChiCTR-IOR-14005679 

最近更新日期:

Date of Last Refreshed on:

2014-12-22 

注册时间:

Date of Registration:

2014-12-01 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

扶正抗癌方联合吉非替尼治疗EGFR基因突变晚期非小细胞肺癌的多中心、随机、双盲、安慰剂对照研究 

Public title:

Multicentre, randomized, placebo-controlled, double-blind study of gefitinib plus "Fuzheng Kang'ai" decoction versus gefitinib in advanced non-small-cell lung cancer patients with EGFR mutation 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

扶正抗癌方联合吉非替尼治疗EGFR基因突变晚期非小细胞肺癌的多中心、随机、双盲、安慰剂对照研究 

Scientific title:

Multicentre, randomized, placebo-controlled, double-blind study of gefitinib plus "Fuzheng Kang'ai" decoction versus gefitinib in advanced non-small-cell lung cancer patients with EGFR mutation 

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:

杨小兵 

研究负责人:

吴万垠 

Applicant:

Xiaobing Yang 

Study leader:

Wanyin Wu 

申请注册联系人电话:

Applicant telephone:

+86 13580309705 

研究负责人电话:

Study leader's telephone:

+86 13078869078 

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:

yangxiaobing2002@126.com 

研究负责人电子邮件:

Study leader's E-mail:

wwanyin@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:

广州市荔湾区芳村涌岸街36号 

研究负责人通讯地址:

广州市荔湾区芳村涌岸街36号 

Applicant address:

No 36, Huadi Yong'An Street, Fangcun District, Guangzhou 510370 

Study leader's address:

No 36, Huadi Yong'An Street, Fangcun District, Guangzhou 510370 

申请注册联系人邮政编码:

Applicant postcode:

510370 

研究负责人邮政编码:

Study leader's postcode:

510370 

申请人所在单位:

广东省中医院 

Applicant's institution:

Guangdong Provincial Hospital 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:

ref: B2014-059-01 

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:

广东省中医院伦理委员会 

Name of the ethic committee:

Institutional Ethics Committee of Guangdong Provincial Hospital of Traditional Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

 

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:

广东省中医院 

Primary sponsor:

Guangdong Provincial Hospital of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

广州市荔湾区芳村涌岸街36号 

Primary sponsor's address:

No 36, Huadi Yong'An Street, Fangcun District, Guangzhou 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

广东

市(区县):

广州

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

广东省中医院

具体地址:

广州市荔湾区芳村涌岸街36号

Institution
hospital:

Guangdong Provincial Hospital of Traditional Chinese Medicine

Address:

No 36, Huadi Yong'An Street, Fangcun District, Guangzhou

经费或物资来源:

广东省中医院 

Source(s) of funding:

Guangdong Provincial Hospital of Traditional Chinese Medicine 

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:

其它 

Study phase:

N/A 

研究目的:

了解扶正抗癌方联合吉非替尼治疗EGFR基因突变晚期非小细胞肺癌是否能提高吉非替尼疗效及减轻其毒副反应。 

Objectives of Study:

The purpose of this study is to determine if "Fuzheng Kang'ai (FZKA, a traditional Chinese herbal medicine)" decoction plus gefitinib have longer progression-free survival and with less toxicity in advanced non-small-cell lung cancer patients with EGFR mutation than gefitinib alone. 

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:

* 病理诊断属非小细胞肺癌; * 临床分期为ⅢB或Ⅳ期的患者; * EGFR基因突变(ARMS法); * 年龄在18~80岁之间; * 行为状态PS(ECOG) 0-2; * 局部病灶和/或远处转移病灶可测量或可评估; * 骨髓、肝、肾、心、肺机能正常者; * 知情同意参加本研究,签署知情同意书,依从性好,可随访者。 

Inclusion criteria

1. With histologically or cytologically confirmed stage IIIB or IV non-small-cell lung cancer with histologic features of adenocarcinoma, squamous-cell carcinoma or adeno-squamous carcinoma; 2. Aged from 18-80 years old; 3. Harbouring activating EGFR mutations (either exon 19 deletion or L858R in exon 21); 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2; 5. No previous chemotherapy or biologic or immunologic therapy; 6. Measurable lesion according to the Response Evaluation Criteria in Solid Tumours (RECIST); 7. Adequate organ function; 8. Good compliance and voluntarily sign a written informed consent. 

排除标准:

* 对吉非替尼或扶正抗癌方过敏者; * 既往接受过抗EGFR治疗; * 预计生存期小于2个月; * 肺间质性疾病病史; * 不能控制的全身疾病(如呼吸、心血管、肝脏或肾脏疾病); * 有症状脑转移未得到控制者; * 有活动性的重复癌者; * 恶性胸腔、腹腔积液者; * 活动性重复癌; * 妊娠或哺乳者。 

Exclusion criteria:

1. Severe hypersensitivity to gefitinib or any component of FZKA; 2. Received previous drug therapy that had targeted EGFR; 3. Eexpected life expectancy less than 2 months; 4. Had a history of interstitial lung disease; 5. Any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic, or renal disease); 6. Diagnosed with central nervous system (CNS) metastasis that have not yet been treated with surgery and/or radiation; 7. Poorly controlled pleural effusion; 8. Pericardial effusion or ascites necessitating drainage; 9. Active double cancer; 10. Patients in pregnancy or breast-feeding. 

研究实施时间:

Study execute time:

From2015-01-01To 2017-12-31 

征募观察对象时间:

Recruiting time:

From2015-01-01To 2017-12-31 

干预措施:

Interventions:

组别:

治疗组

样本量:

35

Group:

Treatment group

Sample size:

干预措施:

吉非替尼联合扶正抗癌方颗粒

干预措施代码:

Intervention:

gefitinib plus FZKA granule

Intervention code:

组别:

对照组

样本量:

35

Group:

Control group

Sample size:

干预措施:

吉非替尼联合安慰剂

干预措施代码:

Intervention:

gefitinib plus placebo granule

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

广东省中医院 

单位级别:

三级甲等 

Institution
hospital:

Guangdong Provincial Hospital of Traditional Chinese Medicine  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

疾病无进展生存时间

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:

安全性

指标类型:

次要指标 

Outcome:

Safety

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:

组织

组织:

Sample Name:

tissue

Tissue:

lung

人体标本去向

使用后保存 

说明

病理科保存

Fate of sample:

Preservation after use 

Note:

Stored by pathology department

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):

由计算机按1:1比例随机产生

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

Random assignment will be performed after consent is obtained by using a computer generated, blocked random-allocation sequence with a 1:1 ratio.

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):

是否共享原始数据:

IPD sharing

否No

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:

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2014-12-01
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