今天是:2019-06-17 星期一

DC Bead M1与超液化碘油化疗栓塞治疗原发性肝癌的有效性及安全性研究
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注册号:

Registration number:

ChiCTR1900023798 

最近更新日期:

Date of Last Refreshed on:

2019-06-12 

注册时间:

Date of Registration:

2019-06-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

DC Bead M1与超液化碘油化疗栓塞治疗原发性肝癌的有效性及安全性研究 

Public title:

Safety and effeficacy of drug-eluting beads chemoembolization for hepatocelluar carcinoma: comparison of DC Bead M1 versus Lipidol 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

DC Bead M1与超液化碘油化疗栓塞治疗原发性肝癌的有效性及安全性研究 

Scientific title:

Safety and effeficacy of drug-eluting beads chemoembolization for hepatocelluar carcinoma: comparison of DC Bead M1 versus Lipidol 

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:

肖煜东 

研究负责人:

肖煜东 

Applicant:

Xiao Yudong 

Study leader:

Xiao Yudong 

申请注册联系人电话:

Applicant telephone:

+86 13637403027 

研究负责人电话:

Study leader's telephone:

+86 13637403027 

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:

546874341@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

546874341@qq.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:

湖南省长沙市人民中路139号中南大学湘雅二医院放射介入科 

研究负责人通讯地址:

湖南省长沙市人民中路139号中南大学湘雅二医院放射介入科 

Applicant address:

139 Middle Renmin Road, Changsha, Hunan, China  

Study leader's address:

139 Middle Renmin Road, Changsha, Hunan, 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:

中南大学湘雅二医院 

Applicant's institution:

Intervention Department, The Second Xiangya Hospital of Central South University 

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:

(2019)伦审【科】第(058)号 

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:

中南大学湘雅二医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of the Second Xiangya Hospital of Central South University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-05-07 

伦理委员会联系人:

唐湘祁 

Contact Name of the ethic committee:

Tang Xiangqi 

伦理委员会联系地址:

湖南省长沙市人民中路139号 

Contact Address of the ethic committee:

139 Middle Renmin Road, Changsha, Hunan, 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:

中南大学湘雅二医院放射介入科 

Primary sponsor:

Intervention Department of the Second Xiangya Hospital of Central South University 

研究实施负责(组长)单位地址:

湖南省长沙市人民中路139号 

Primary sponsor's address:

139 Middle Renmin Road, Changsha, Hunan, 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):

湖南省

市(区县):

长沙

Country:

China

Province:

Hunan

City:

Changsha

单位(医院):

中南大学湘雅二医院

具体地址:

人民中路139号

Institution
hospital:

The Second Xiangya Hospital of Central South University

Address:

139 Middle Renmin Road

经费或物资来源:

自筹 

Source(s) of funding:

Self-finance 

研究疾病:

肝癌 

Target disease:

hepatocellular cacinoma 

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:

探索性研究/预试验 

Study phase:

研究目的:

本研究旨在对比DC BeadM1TM与超液化碘油化疗栓塞治疗原发性肝癌的有效性及安全性。 

Objectives of Study:

The purpose of this study was to compare the efficacy and safety of DC BeadM1TM and ultra-lipiodol chemoembolization in the treatment of primary liver cancer. 

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:

Child-Pugh A or B (score 7) ;ECOG PS 0-1;至少有一个未经治疗过的靶病灶;BCLC A/B。 

Inclusion criteria

Child-Pugh A or B (score 7); ECOG PS 0-1; At least one untreated target lesion; BCLC A/B 

排除标准:

年龄<18岁;弥漫型肝癌肿瘤负荷>70%;血管侵犯;肝外转移;大量腹水;胆红素>3.0mg/dl;白蛋白<30g/l;血小板<50×10^9; INR>1.5;5年以内患过其他恶性肿瘤。 

Exclusion criteria:

Aged < 18 years; tumor burden > 70%; vascular invasion; extrahepatic metasis; predominant ascites; bilirubin > 3.0mg/dl; albumin < 30g/l; blood platelets <50×10^9; INR > 1.5; other malignancies within 5 years. 

研究实施时间:

Study execute time:

From2019-06-01To 2020-12-31 

干预措施:

Interventions:

组别:

A组

样本量:

50

Group:

A

Sample size:

干预措施:

DC Bead M1

干预措施代码:

Intervention:

DC Bead M1

Intervention code:

组别:

B组

样本量:

50