今天是:2019-06-26 星期三

解毒颗粒治疗晚期肝癌多中心前瞻性随机对照研究
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注册号:

Registration number:

ChiCTR1900022789 

最近更新日期:

Date of Last Refreshed on:

2019-05-12 

注册时间:

Date of Registration:

2019-04-25 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

解毒颗粒治疗晚期肝癌多中心前瞻性随机对照研究 

Public title:

A multi-center prospective randomized controlled study for Jiedu Granule in the treatment of advanced hepatocellular carcinoma 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

解毒颗粒治疗晚期肝癌多中心前瞻性随机对照研究 

Scientific title:

A multi-center prospective randomized controlled study for Jiedu Granule in the treatment of advanced 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:

赵河通 

研究负责人:

翟笑枫 

Applicant:

Hetong Zhao 

Study leader:

Xiaofeng Zhai 

申请注册联系人电话:

Applicant telephone:

+86 021 31161950 

研究负责人电话:

Study leader's telephone:

+86 021 31161950 

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:

183773508@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

zhxfch@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:

上海市杨浦区长海路168号长海医院 

研究负责人通讯地址:

上海市杨浦区长海路168号长海医院 

Applicant address:

168 Changhai Road, Yangpu District, Shanghai, China  

Study leader's address:

168 Changhai Road, Yangpu District, Shanghai, 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:

海军军医大学长海医院中医系 

Applicant's institution:

Changhai Hospital of Traditional Chinese Medicine,Navy Military Medical 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:

ChiECRCT20190044 

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:

中国注册临床试验伦理委员会 

Name of the ethic committee:

China Ethics Committee of Registering Clinical Trials 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-04-01 

伦理委员会联系人:

米娜 

Contact Name of the ethic committee:

Mina 

伦理委员会联系地址:

中国香港特别行政区九龙塘浸会大学道中国临床试验注册中心香港中心 

Contact Address of the ethic committee:

Clinical Trial Registry Hong Kong Center, Hong Kong Baptist University Road, Hong Kong SAR, 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:

海军军医大学长海医院中医系 

Primary sponsor:

Changhai Hospital of Traditional Chinese Medicine,Navy Military Medical University  

研究实施负责(组长)单位地址:

上海市杨浦区长海路168号长海医院 

Primary sponsor's address:

168 Changhai Road, Yangpu 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):

Country:

China

Province:

Shanghai

City:

单位(医院):

长海医院

具体地址:

杨浦区长海路168号

Institution
hospital:

Changhai Hospital

Address:

168 Changhai Road, Yangpu District

经费或物资来源:

自筹 

Source(s) of funding:

self-funded 

研究疾病:

肝细胞癌 

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:

N/A 

研究目的:

评估解毒颗粒在晚期肝细胞癌患者中的疗效和安全性。 

Objectives of Study:

We aim to evaluate the efficacy and safety of Jiedu Granule in Advanced 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 

Study design:

Parallel 

纳入标准:

1.年龄为≥18周岁,男女不限; 2.经病理组织学或临床诊断为肝细胞癌; 3.无介入化疗和放疗适应证,靶向治疗失败或不愿接受靶向药物治疗者; 4.巴塞罗那肝癌临床分期(BCLC) C、D期; 5.距最近一次TACE术治疗超过1个月,或距最近一次放射治疗超过2个月; 6.预计生存期2个月以上; 7.愿意参加临床试验,并签署知情同意书。 

Inclusion criteria

1. Male or female aged older than 18 years; 2. Histologically diagnosed HCC, OR clinically diagnosed HCC; 3. Documented progression with or intolerance to target therapy for advanced HCC and no indication of transarterial chemoembolization and radiotherapy; 4. Stage C and D according to the BCLC staging classification; 5. More than 1 month from the last TACE or 2 months from the last radiotherapy. 6. The estimated survival time is more than 2 months; 7. Willing to participate in clinical trials and sign informed consent. 

排除标准:

1.入组前4周内参加过其他抗肿瘤药物临床试验的; 2.入组前4周内接受过包括放疗(姑息性放疗除外)、经皮乙醇注射、射频消融术、肝动脉栓塞治疗、冷冻消融术); 3.接受过实体器官移植术; 4.患者既往曾记录有脑转移、软脑膜病变或未得到控制的脊髓压迫; 5.入组前6个月内发生食管或胃静脉曲张破裂出血; 6.研究者判断其他可能影响临床研究进行及研究结果判定的情况。 

Exclusion criteria:

1. currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment; 2. Local treatment including radiotherapy (except palliative radiotherapy), percutaneous ethanol injection, radiofrequency ablation, transarterial embolization, or cryotherapy administered within 4 weeks prior to enrollment; 3. Had a solid organ transplant; 4. Presence of brain or leptomeningeal metastases; 5. Has had esophageal or gastric variceal bleeding within the last 6 months; 6. the researchers consider those who were not suitable for inclusion. 

研究实施时间:

Study execute time:

From2019-04-30To 2022-01-01 

干预措施:

Interventions:

组别:

试验组

样本量:

50

Group:

Experimental group

Sample size:

干预措施:

解毒颗粒

干预措施代码:

Intervention:

Jiedu Granule

Intervention code:

组别:

对照组

样本量:

50

Group:

Control group

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

Placebo

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):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

长海医院 

单位级别:

三级甲等 

Institution
hospital:

Changhai Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

总生存时间

指标类型:

主要指标 

Outcome:

Overall 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:

无进展生存时间

指标类型:

次要指标 

Outcome:

PFS

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:

正在进行

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):

中心随机化

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

Center randomization

盲法:

双盲

Blinding:

Double blind

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

即时公开/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):

以论文和文章的形式公开

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

Open in the form of papers and articles

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:

病例记录表和电子采集和管理

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

Case Record Table and Electronic Data Capture

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-04-25
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