ChiCTR-ONRC-12002936 版本V1.1 版本创建时间2016/1/2 15:12:23 中国临床试验注册中心

审核状态:

Project audit state:

通过审核

Successful

注册号:

Registration number:

ChiCTR-ONRC-12002936 

最近更新时间:

Date of Last Refreshed on:

2016/1/2 15:03:34 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

填写语言:

中文和英文  

Language:

Chinese And English  

注册题目:

脐血CIK细胞静脉输注联合TACE治疗原发性肝癌疗效和安全性的对照研究 

Public title:

A controlled trail on the efficacy and safety of TACE combined with umbilical cord blood cytokine-induced killer (CIK) cells infusion in hepatocellular carcinoma 

注册题目简写:

 

Public title acronym:

 

研究课题的正式科学名称:

脐血CIK细胞静脉输注联合TACE治疗原发性肝癌疗效和安全性的对照研究 

Scientific title:

the efficacy and safety of TACE combined with umbilical cord blood cytokine-induced killer (CIK) cells infusion in hepatocellular carcinoma 

研究课题的正式科学名称简写:

 

Scientific title acronym:

 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

刘波 

研究负责人:

陈从新 

Applicant:

Bo Liu 

Study leader:

Congxin Chen 

申请注册联系人电话:

Applicant telephone:

+86 18909696241 

研究负责人电话:

Study leader's telephone:

+86 18909696271 

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:

18909696241@163.com 

研究负责人电子邮件:

Study leader's E-mail:

congxinc@yahoo.com.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:

中国安徽合肥市长江西路424号 

研究负责人通讯地址:

中国安徽合肥市长江西路424号 

Applicant address:

424 Changjiang Road West, Hei'fei, Anhui, China 

Study leader's address:

424 Changjiang Road West, Hei'fei, Anhui, 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:

中国人民解放军第105医院感染病科 

Applicant's institution:

Department of Infection, 105th Hospital of PLA 

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:

2012A08 

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:

中国人民解放军第105医院伦理委员会 

Name of the ethic committee:

Ethic Committee of the 105th Hospital of PLA 

伦理委员会批准日期:

Date of approved by ethic committee:

2012-04-09 

国家FDA批准文号:

Approved No. of SFDA:

国家FDA批准附件:

Approved file of SFDA:

国家FDA批准日期:

Date of approved by SFDA:

2013-08-26

研究实施负责(组长)单位:

中国人民解放军第105医院 

Primary sponsor:

The 105th Hospital of PLA 

研究实施负责(组长)单位地址:

中国安徽合肥市长江西路424号 

Primary sponsor's address:

424 Changjiang Road West, Hei'fei, Anhui, 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):

安徽

市(区县):

合肥

Country:

China

Province:

Anhui

City:

Hefei

单位(医院):

中国人民解放军第105医院

具体地址:

中国安徽合肥市长江西路424号

Institution
hospital:

The 105st Hospital of PLA

Address:

424 Changjiang Road West, Hei'fei, Anhui, China

经费或物资来源:

中国人民解放军第105医院学科支持 

Source(s) of funding:

Discipline supporting program funding from the 105th Hospital of PLA 

研究疾病:

确诊的原发性肝癌 

Target disease:

Diagnosed with primary hepatic 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:

II期临床试验 

Study phase:

II (Phase II study) 

研究目的:

考察脐血CIK细胞输注治疗中晚期原发性肝癌的疗效和安全性,为原发性肝肺癌的治疗寻找一种更为安全有效的疗法 

Objectives of Study:

Study of umbilical cord blood CIK cell infusion treatment of advanced primary hepatic carcinoma of the efficacy and safety for the treatment of primary hepatic carcinoma to find a safer and more effective therapy 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

(1)所有患者病灶肿块直径为2cm~10cm,局限于肝内,无门脉癌栓及远处转移; (2)肝功能为 Child—Pugh A或B级,KPS评分≥7O分,预计生存时间≥6个月 ; (3)患者或家属均签署CIK细胞治疗知情同意书,并报医院伦理委员会批准。 

Inclusion criteria

(1) The diameter of tumor in all patients is between 2cm 10cm, Swelling limited to liver, no portal cancerous thrombus and distant metastasis; (2) The grade of liver function is Child - Pugh A or B, KPS >=7O, and expected survival time is more than 6 months; (3) patients and relatives signed CIK treatmen consent, and received approval of the hospital ethics committee. 

排除标准:

1) 心血管疾病史:充血性心力衰竭>纽约心脏病协会( NYHA) II级,有不稳定心绞痛的患者(静息时出现心绞痛症状)或新发生的心绞痛(最近3个月内开始发作)或最近6个月内发生心肌梗塞的患者; 2) 全身状况差、恶病质;或合并其他有致命危险的疾病; 3) 肝功能实验室检查ALT、AST高于正常值上限2.0倍以上;或肾功能TBIL、Bun超过正常上限值1.0倍以上,或Cr超过正常上限; 4) 活动性感染; 5) 患者为妊娠或哺乳期妇女; 6) 现在、近期(前1天-4周内)或将加入另一试验药物的临床研究的; 7) 研究者认为不能入选的其他情况:如有将影响入组病例参加或完成临床研究(例如精神疾患、药物滥用、HIV感染者等),或影响对临床研究结果进行分析。 

Exclusion criteria:

1) history of cardiovascular disease: congestive heart failure> New York Heart Association (NYHA) II level, patients with unstable angina (angina symptoms occur at rest) or new onset of angina (the last 3 months of onset) or recent myocardial infarction within 6 months of patients; 2) poor body condition, cachexia; Or in combination with other fatal diseases; 3) laboratory tests of liver function ALT, AST 2.0 times higher than the upper limit of normal; Or renal TBIL, Bun more than 1.0 times the upper limit of normal, or Cr above the normal upper limit; 4) active infection; 5) patients pregnant or lactating women; 6) Now, the recent (-4 weeks, 1 day before) or will join another clinical drug trial research; 7) The researchers believe that other circumstances can not be selected: If the impact into the group of patients to participate in or completion of clinical studies (such as mental illness, substance abuse, HIV infection, etc.), or affect the results of the analysis of clinical studies. 

研究实施时间:

Study execute time:

From2012-04-10To 2014-09-21 

干预措施:

Interventions:

组别:

A

样本量:

50

Group:

A

Sample size:

干预措施:

脐血CIK细胞输注+TACE

干预措施代码:

Intervention:

umbilical cord blood CIK cell infusion + TACE

Intervention code:

组别:

B

样本量:

50

Group:

B

Sample size:

干预措施:

TACE

干预措施代码:

Intervention:

TACE

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

测量指标:

Outcomes:

指标中文名:

近期疗效评估: 疾病控制率DCR(CR+PR+SD)

指标类型:

主要指标 

Outcome:

Clinical effect Evaluation: assess short-term effect: disease control rate DCR (CR+PR+SD)

Type:

Primary indicator 

测量时间点:

近期疗效

测量方法:

Measure time point of outcome:

short term effect

Measure method:

指标中文名:

疾病无进展生存期

指标类型:

主要指标 

Outcome:

Progression-Free Srvival, PFS

Type:

Primary indicator 

测量时间点:

远期疗效

测量方法:

Measure time point of outcome:

long term effect

Measure method:

指标中文名:

免疫学疗效的评价

指标类型:

次要指标 

Outcome:

immunology indeces

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:

脐带血

Sample Name:

blood

Tissue:

umbilical cord blood

人体标本去向

使用后销毁 

说明

存于中国人民解放军第105医院实验室2年

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 26 years
最大 Max age 78 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):

非随机试验,根据患者的入组的先后次序生成

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

non-randomized,continuous enrolled patients

UTN(全球唯一识别码):

盲法:

Blinding:

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

Organizer institution (leader institution):

资料收集汇总单位:

Data collection Institution:

资料管理单位:

Data management Institution:

资料分析单位:

Data analysis Institution:

注册人:

Name on Registration:

 2012-12-02