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Randomized controlled study of bicarbonate-enhanced and conventional transarterial chemoembolization in treatment of hepatocellular carcinoma
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注册号:

Registration number:

ChiCTR-IOR-14005319 

最近更新日期:

Date of Last Refreshed on:

2014-10-20 

注册时间:

Date of Registration:

2014-10-08 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

碳酸氢钠增强的肝动脉插管化疗性栓塞与常规肝动脉插管化疗性栓塞治疗肝细胞肝癌疗效的随机对照研究 

Public title:

Randomized controlled study of bicarbonate-enhanced and conventional transarterial chemoembolization in treatment of hepatocellular carcinoma 

研究课题的正式科学名称:

碳酸氢钠增强的肝动脉插管化疗性栓塞与常规肝动脉插管化疗性栓塞治疗肝细胞肝癌疗效的随机对照研究 

Scientific title:

Bicarbonate-enhanced and conventional transarterial chemoembolization for hepatocellular carcinoma 

研究课题代号(代码):

Study subject ID:

2013CB911303 

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:

吴昊 

研究负责人:

胡汛 

Applicant:

Hao Wu 

Study leader:

Xun Hu 

申请注册联系人电话:

Applicant telephone:

+86 15868882839 

研究负责人电话:

Study leader's telephone:

+86 0571 87783656 

申请注册联系人传真 :

Applicant Fax:

Hao Wu 

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:

haow@zju.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

Huxun@zju.edu.cn 

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:

杭州市解放路88号浙江大学肿瘤研究所 

研究负责人通讯地址:

杭州市解放路88号浙江大学肿瘤研究所 

Applicant address:

Zhejiang University Cancer Institute, 88# Jiefang Road, Hangzhou, Zhejiang 

Study leader's address:

Zhejiang University Cancer Institute, 88# Jiefang Road, Hangzhou, Zhejiang 

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:

浙江大学医学院附属第二医院 

Applicant's institution:

the Second Affiliated Hospital of Zhejiang Univers 

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:

(2012)伦审研第(24)号 

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:

浙江大学医学院附属第二医院医学伦理委员会 

Name of the ethic committee:

The ethic committee of the second hospital of Zhejiang university School of Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2012-05-30 

研究实施负责(组长)单位:

浙江大学医学院附属第二医院 

Primary sponsor:

The Second affiliated Hospital, Zhejiang University School of Medicine 

研究实施负责(组长)单位地址:

中国浙江杭州市解放路88号 

Primary sponsor's address:

88 Jiefang Road, Hangzhou, Zhejiang, 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):

浙江

市(区县):

杭州

Country:

China

Province:

Zhejiang

City:

Hangzhou

单位(医院):

The Second affiliated Hospital, Zhejiang Universit

具体地址:

中国浙江杭州市解放路88号

Institution
hospital:

The Second affiliated Hospital, Zhejiang Universit

Address:

88 Jiefang Road, Hangzhou, Zhejiang, China

经费或物资来源:

国家973计划(2013CB911303)和教育部重点实验室基础研究基金 

Source(s) of funding:

China National 973 project (2013CB911303) and the Fundamental Research Funds for the Central Univers 

研究疾病:

肝癌 

Target disease:

hepatocellular carcinoma 

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:

Other 

研究目的:

观察肝癌内注入碳酸氢钠注射液是否能增强肝动脉插管化疗性栓塞治疗肝细胞肝癌疗效。 

Objectives of Study:

To observe if bicarbonate can enhance the therapeutic efficacy of transarterial chemoembolization in treatment of hepatocellular carcinoma 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照试验 

Study design:

Randomized parallel controlled trial 

纳入标准:

1. 经病理组织学确诊或符合肝癌临床诊断标准的肝细胞癌患者,并且未接受任何其它治疗; 2. ECOG评分 0-1分; 3. 肝癌BCLC分期:B期或C期; 4. 术前Child-Pugh评分:A级或B级; 5. 经研究者判断,能遵守试验方案; 6. 患者自愿参加本次临床试验,理解研究程序且能够书面签署知情同意书。 

Inclusion criteria

1. Hepatocellular carcinoma is confirmed by tissue pathology or clinical diagnosis standard, and does not receive any therapy; 2. ECOG score 0-1; 3. HCC BCLC grading: B or C; 4. Child-Pugh score prior to therapy: A or B; 5. As judged by investigators, the patient can comply with the study protocol; 6. Patient voluntarily participates in this study, understands the process of the study, and is willing to sign the written consent form. 

排除标准:

1. 肝癌BCLC 分期: 0期、A期或 D期; 2.术前Child-Pugh评分:C级(不可纠正); 3. 肿瘤侵犯肝静脉和/或门静脉分支并存在明显的动静脉瘘; 

Exclusion criteria:

1. HCC BCLC grading: 0, A or D; 2. Child-Pugh score prior to therapy: D; 3. Tumor invades liver and/or portal vein or their branches and there is evident vein artery shunt. 

研究实施时间:

Study execute time:

From2014-03-01To  

干预措施:

Interventions:

组别:

cTACE

样本量:

30

Group:

cTACE

Sample size:

干预措施:

常规肝动脉插管化疗性栓塞

干预措施代码:

Intervention:

conventional transarterial chemoembolization

Intervention code:

组别:

bTACE

样本量:

30

Group:

bTACE

Sample size:

干预措施:

碳酸氢钠增强的肝动脉插管化疗性栓塞

干预措施代码:

Intervention:

bicarbonate-enhanced transarterial chemoembolization

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

浙江大学医学院附属第二医院 

单位级别:

三级甲等 

Institution
hospital:

The Second affiliated Hospital, Zhejiang University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

肿瘤响应率

指标类型:

主要指标 

Outcome:

Tumor 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:

生存时间

指标类型:

次要指标 

Outcome:

Survival time

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 30 years
最大 Max age 90 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):

由晁明使用随机数表法产生随机数。

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

generate random number according to principle of random number table by Chao Ming

盲法:

Blinding:

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:

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-bassed public database, please provide the url):

数据保存和管理(说明:数据包括原始记录、病例记录表等数据,采用什么数据库):

The repository and management of the data(Please specify what repository will be used for management of the metadata):

注册人:

Name of Registration:

 2014-10-08
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