今天是:2019-07-21 星期日

CalliSpheres载药栓塞微球加载雷替曲塞栓塞治疗肝细胞肝癌的有效性和安全性以及预后相关分析
下载XML文档

注册号:

Registration number:

ChiCTR1900024097 

最近更新日期:

Date of Last Refreshed on:

2019-07-01 

注册时间:

Date of Registration:

2019-06-25 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

CalliSpheres载药栓塞微球加载雷替曲塞栓塞治疗肝细胞肝癌的有效性和安全性以及预后相关分析 

Public title:

Efficacy, safety and prognosis analysis of transarterial chemoembolization with CalliSpheres drug-eluting bead loaded with raltitrexed for hepatocellular carcinoma 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

CalliSpheres载药栓塞微球加载雷替曲塞栓塞治疗肝细胞肝癌的有效性和安全性以及预后相关分析 

Scientific title:

Efficacy, safety and prognosis analysis of transarterial chemoembolization with CalliSpheres drug-eluting bead loaded with raltitrexed for hepatocellular carcinoma 

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:

韩新巍 

研究负责人:

戴海学 

Applicant:

Xinwei Han 

Study leader:

Haixue Dai 

申请注册联系人电话:

Applicant telephone:

+86 13803842129 

研究负责人电话:

Study leader's telephone:

+86 17721416526 

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:

hanxinwei2006@163.com 

研究负责人电子邮件:

Study leader's E-mail:

daihaixue@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:

郑州市二七区建设东路1号郑州大学第一附属医院 

研究负责人通讯地址:

上海市浦东新区海科路1288号 

Applicant address:

1 Jianshe Road East, Zhengzhou, He'nan, China  

Study leader's address:

1288 Haike Road, Pudong New Area, Shanghai 

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:

郑州大学第一附属医院 

Applicant's institution:

The First Affiliated Hospital of Zhengzhou 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:

械-2018-52 

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:

郑州大学第一附属医院科研和临床试验伦理委员会  

Name of the ethic committee:

Ethics and Scientific Trial Committee of the First Affiliated Hospital of Zhengzhou University  

伦理委员会批准日期:

Date of approved by ethic committee:

2019-03-01 

伦理委员会联系人:

田丽 

Contact Name of the ethic committee:

Li Tian 

伦理委员会联系地址:

郑州市建设东路1号郑州大学第一附属医院 

Contact Address of the ethic committee:

The First Affiliated Hospital of Zhengzhou University, 1 Jianshe Road East, Zhengzhou, He'nan, 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:

郑州大学第一附属医院 

Primary sponsor:

The First Affiliated Hospital of Zhengzhou University  

研究实施负责(组长)单位地址:

郑州市建设东路1号 

Primary sponsor's address:

1 Jianshe Road East, Zhengzhou, He'nan, 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):

江苏

市(区县):

Country:

China

Province:

Jiangsu

City:

单位(医院):

苏州恒瑞迦俐生生物医药科技有限公司

具体地址:

苏州高新区科技城锦峰路8号

Institution
hospital:

Suzhou Hengrui Jiasheng Biomedical Technology Co., Ltd.

Address:

8 Jinfeng Road, Science and Technology City, Suzhou High-tech Zone

经费或物资来源:

自筹 

Source(s) of funding:

self-financing 

研究疾病:

肝细胞肝癌 

Target disease:

Hepatocellular carcinoma 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

本研究拟在讨论影响肝癌介入治疗预后的相关因素并进行分析,以建立个体化的治疗方案,以期为准确评估病情、判断预后从而延长受试者生存期提供有价值的参考依据。 

Objectives of Study:

Discuss and analyze the factors affecting the prognosis of interventional treatment of liver cancer, in order to establish an individualized treatment plan, in order to provide a valuable reference for accurate assessment of the condition, prognosis and prolong the survival of the subject. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

1) 年龄≥18岁、性别不限; 2) 经病理组织学或临床诊断为肝细胞肝癌; 3) 不适合/不接受手术切除/经皮消融治疗或消融治疗失败; 4) 肝功能Child-Pugh A级或B级; 5) BCLC分期为B期; 6) 肝区肿瘤结节≤5个,且结节总大小≤10cm; 7) ECOG评分 ≤2分; 8) 预计生存期≥3个月; 9) 理解并签署知情同意书。 

Inclusion criteria

1. Aged >=18 years old male and female; 2. Patients who was confirmed as hepatocellular carcinoma by Histopathological or clinical diagnosis; 3. Unsuitable/not accepted surgical resection/percutaneous ablation or ablation failure; 4. Child-Pugh grade A or grade B; 5. BCLC stage is B; 6. The tumor nodules in the liver area are <=5, and the total size of the nodules is <=10cm; 7. ECOG score <=2 points; 8. Estimated survival period >=3 months; 9. Understood and signed the informed consent form. 

排除标准:

1) 有其他原发性肿瘤; 2) 妊娠或哺乳期妇女; 3) 肝功能Child-Pugh C级; 4) BCLC分期C、D期; 5) 严重的肝细胞性黄疸; 6) 存在活动性内出血疾病、明确出血迹象或严重的凝血功能障碍,严重感染或血友病受试者; 7) 心、肺、肾等重要脏器衰竭; 8) 对雷替曲塞及造影剂过敏; 9) 严重动静脉瘘不可封堵; 10) 不能对自身感受确切表达或依从性差。 

Exclusion criteria:

1. have other primary tumors; 2. pregnant or lactating women; 3. Child-Pugh C grade; 4. BCLC stage was C and D; 5. severe hepatic jaundice; 6. Subjects with active internal bleeding, clear signs of bleeding or severe coagulopathy, severe infection or hemophilia; 7. heart, lung, kidney and other important organ failure; 8. allergic to raltitrexed and contrast agents; 9. Severe arteriovenous fistula can not be blocked; 10. Patients who cannot express exactly his/her feelings or had poor compliance. 

研究实施时间:

Study execute time:

From2019-06-30To 2022-06-30 

干预措施:

Interventions:

组别:

试验组

样本量:

100

Group:

Case series

Sample size:

干预措施:

CalliSpheres可载药栓塞微球加载雷替曲塞

干预措施代码:

Intervention:

CalliSpheres drug-eluting bead loaded with raltitrexed

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

河南 

市(区县):

 

Country:

China 

Province:

He'nan 

City:

 

单位(医院):

郑州大学第一附属医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital of Zhengzhou University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

无进展生存期

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:

不良反应

指标类型:

次要指标 

Outcome:

Adverse Event

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:

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 100 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):

不适用

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

N/A

盲法:

N/A

Blinding:

N/A

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/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):

文章发表或其他形式

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

publish as original artical or other forms

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表和EDC

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

CRF and EDC

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-06-25
返回列表