今天是:2019-07-21 星期日

乙肝肝癌术后抗病毒治疗的真实世界研究
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注册号:

Registration number:

ChiCTR1900024098 

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:

乙肝肝癌术后抗病毒治疗的真实世界研究 

Public title:

A real world study for postoperative antiviral therapy in patients with hepatitis B related hepatocellular carcinoma  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

乙肝肝癌术后抗病毒治疗的真实世界研究 

Scientific title:

A real world study for postoperative antiviral therapy in patients with hepatitis B related 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:

刘渠 

研究负责人:

胡明根 

Applicant:

Liu Qu 

Study leader:

Hu minggen 

申请注册联系人电话:

Applicant telephone:

+86 18519250589 

研究负责人电话:

Study leader's telephone:

+86 13910385269 

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:

leonliu52@163.com 

研究负责人电子邮件:

Study leader's E-mail:

hmg301@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:

北京市海淀区复兴路28号 

研究负责人通讯地址:

北京市海淀区复兴路28号 

Applicant address:

28 Fuxing Road, Beijing, China  

Study leader's address:

28 Fuxing Road, Beijing, 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:

解放军总医院 

Applicant's institution:

Chinese People's Liberation Army (PLA) General Hospital  

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:

S2019-084-01 

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:

中国人民解放军总医院医学伦理委员会 

Name of the ethic committee:

Ethics Committee of Chinese People's Liberation Army (PLA) General Hospital  

伦理委员会批准日期:

Date of approved by ethic committee:

2019-04-25 

伦理委员会联系人:

曹江 

Contact Name of the ethic committee:

Cao Jiang 

伦理委员会联系地址:

北京市海淀区复兴路28号 

Contact Address of the ethic committee:

28 Fuxing Road, Beijing, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 010 66937166 

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:

解放军总医院 

Primary sponsor:

Chinese People's Liberation Army (PLA) General Hospital 

研究实施负责(组长)单位地址:

北京市海淀区复兴路28号 

Primary sponsor's address:

28 Fuxing Road, Beijing, 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):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

解放军总医院

具体地址:

北京市海淀区复兴路28号

Institution
hospital:

Chinese People's Liberation Army (PLA) General Hospital

Address:

28 Fuxing Road, Beijing, China

经费或物资来源:

自筹 

Source(s) of funding:

Self-funding 

研究疾病:

肝癌 

Target disease:

Liver cancer 

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:

上市后药物 

Study phase:

研究目的:

筛选出适合我国国情的乙肝肝癌术后抗病毒治疗方案  

Objectives of Study:

To screening the most suitable antiviral therapy for patients with hepatitis B–related hepatocellular carcinoma in China 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

一般入选标准: 1.取得患者或其法定代理人签署的知情同意书; 2.依从研究方案和随访流程; 3.患者年龄≥18岁且≤70岁,性别不限; 4.无外科手术禁忌,能耐受根治性手术,ECOG 行为状态评分 0~1, 预期寿命≥ 12 周,ASA 评分≤2。 与疾病有关的入选标准: 5.术前根据临床症状、影像学检查、肿瘤标志物等辅助检查及术后病理,确诊为肝细胞癌; 6.HBsAg阳性且HBV-DNA阳性,未经抗病毒治疗(慢性乙型肝炎防治指南(2015年版)); 7.巴塞罗那临床肝癌(BCLC)分期为0,A,B期,无肝外转移及大血管侵犯; 8.根据原发性肝癌诊疗规范(2017年版),术前评估肿瘤可根治性切除:1)肝静脉、门静脉、胆管及下腔静脉未见肉眼癌栓;2)临近脏器侵犯,无肝门淋巴结或远处转移;3)肝脏切缘距肿瘤边界>1cm,或R0切除;4)术后2个月行超声、CT、MRI检查未发现肿瘤病灶;5)术前AFP升高,术后2月AFP定量测定,其水平在正常范围。 血液学、生化和器官功能: 9.血红蛋白≥ 9.0 g/dL(可以通过输血维持或超过这个水平); 10.中性粒细胞绝对计数≥1.5×109/L; 11.血小板计数≥50×109/L; 12.肝功能Child-Pugh分级为A-B级; 13.肌酐≤1.25 倍正常值上限;且肌酐清除率≥60mL/min; 14.未曾接受抗凝治疗的患者凝血酶原时间国际标准化比值(INR)≤1.5,部分凝血活酶时间(APTT)≤1.5 倍正常值上限。接受全量或胃肠外抗凝药 物治疗的患者只要在进入临床研究前抗凝药物的剂量稳定至少 2 周,并且 凝血检测试验的结果在当地治疗所限制的范围以内均可以进入临床试验; 15.育龄期妇女(15~49 岁)必须在开始治疗前 7 天内行尿妊娠试验且结果为阴性  

Inclusion criteria

1. Obtain informed consent signed by the patient or his or her legal agent; 2. Compliance with the study plan and follow-up procedure; 3. Aged 18 to 70 years old male and female; 4. No surgical contraindications, able to tolerate radical surgery, ECOG behavioral status score 0-1, life expectancy >=12 weeks, ASA score <=2. Inclusion criteria related to disease: 5. Diagnosed as hepatocellular carcinoma preoperatively according to clinical symptoms, imaging examination, tumor markers and other auxiliary examinations and postoperative pathology; 6. HBsAg positive and HBV-DNA positive, without antiviral treatment (guidelines for the prevention and treatment of chronic hepatitis B (2015 edition)); 7. Barcelona clinical liver cancer (BCLC) stage 0, stage A, stage B, no extrahepatic metastasis and macrovascular invasion; 8. According to the diagnosis and treatment specifications for primary liver cancer (2017 edition), preoperative assessment of radical resection of the tumor is as follows: 1) No visual obstruction in hepatic vein, portal vein, bile duct and inferior vena cava; 2) invasion of adjacent organs, no hilar lymph node or distant metastasis; 3) liver resection margin from tumor boundary >1cm, or R0 resection; 4) ultrasonography, CT and MRI were performed 2 months after surgery, and no tumor lesions were found; 5) AFP was elevated before operation and quantitatively measured at 2 months after operation, and its level was in the normal range. Hematology, biochemistry and organ function: 9. Hemoglobin >=9.0 g/dL (this level can be maintained or exceeded by transfusion); 10. Absolute count of neutrophils >=1.5 x 10^9/L; 11. Platelet count >=50x10^9/L; 12. Liver function child-pugh graded a-b; 13. creatinine <=1.25 times upper limit of the normal value; The clearance rate of creatinine >=60mL/min; 14. The internationally standardized ratio (INR) of prothrombin time ≤ 1.5 for patients who have not received anticoagulation therapy, and APTT <=1.5 times the upper limit of normal value. Patients receiving full doses or treatment with parenteral anticoagulants are admitted to clinical trials as long as the doses of anticoagulants are stable for at least 2 weeks before entering the clinical study, and the results of the coagulation test are within the limits of local treatment; 15. Women of reproductive age (15 to 49 years old) must undergo a urinary pregnancy test within 7 days before treatment and the results are negative.  

排除标准:

1.最近5年之内出现其他部位的恶性肿瘤;脑、肺、骨转移或腹腔淋巴结转移的病人; 2.随机入组前进行过任何药物的抗病毒治疗; 3.正在参加其他临床试验; 4.心电图异常或临床上有明显的心脏病,如:充血性心衰,有症状的冠心病,心律失常,临床表现明显的心脏病,或过去12个月发作过心肌缺血;严重的感染,败血症,严重的代谢紊乱或糖尿病;消化性溃疡活动期需治疗者,吸收障碍者,上消化道完整性破坏者; 5.有对研究药物或类似结构药物过敏史; 6.妊娠、哺乳期妇女; 7.有可能损害患者安全或研究数据完整性的任何状况,包括严重医学危险因素、医学状况、及实验室异常; 8.HCV、HIV、梅毒感染; 9.临床上有明显精神异常,有中枢神经系统异常的病史或有发作史; 10.研究者认为不宜参加本试验 11.患者不愿或不能依从研究程序,或在研究治疗期间可能脱离观察 1 个疗程或以上  

Exclusion criteria:

1. Malignant tumors in other areas within the last 5 years; Patients with brain, lung, bone metastases or abdominal lymph node metastases; 2. Antiviral treatment with any drug before this trial; 3. Patients who are participating in other clinical trials; 4. Abnormal ECG or clinically significant heart disease such as congestive heart failure, symptomatic coronary heart disease, arrhythmia, clinically significant heart disease, or myocardial ischemia in the past 12 months; Severe infection, sepsis, severe metabolic disorders or diabetes; Those who need treatment during active period of peptic ulcer, those who have difficulty in absorption, and those who damage the integrity of upper digestive tract; 5. Patients who have a history of allergies to research drugs or similar structures; 6. Women during pregnancy or lactation; 7. Any condition that may compromise patient safety or research data integrity, including serious medical risk factors, medical conditions, and laboratory abnormalities; 8. Infection of HCV, HIV, syphilis; 9. Clinically significant mental abnormalities, a history of central nervous system abnormalities or a history of seizures; 10. The investigator considers it inappropriate to participate in this study; 11. Patients who are unwilling or unable to comply with the study, or may withdraw for one course or more during the treatment.  

研究实施时间:

Study execute time:

From2019-07-01To 2022-07-01 

干预措施:

Interventions:

组别:

A

样本量:

100

Group:

A

Sample size:

干预措施:

恩替卡韦

干预措施代码:

Intervention:

entecavir

Intervention code:

组别:

B

样本量:

100

Group:

B

Sample size:

干预措施:

替诺福韦

干预措施代码:

Intervention:

tenofovir

Intervention code:

组别:

C

样本量:

100

Group:

C

Sample size:

干预措施:

恩替卡韦+胸腺五肽

干预措施代码:

Intervention:

entecavir+thymopentin

Intervention code:

组别:

D

样本量:

100

Group:

D

Sample size:

干预措施:

替诺福韦+胸腺五肽

干预措施代码:

Intervention:

tenofovir+thymopentin

Intervention code:

组别:

E

样本量:

100

Group:

E

Sample size:

干预措施:

恩替卡韦+胸腺法新

干预措施代码:

Intervention:

entecavir+thymalfasin

Intervention code:

组别:

F

样本量:

100

Group:

F

Sample size:

干预措施:

替诺福韦+胸腺法新

干预措施代码:

Intervention:

tenofovir+thymalfasin

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

解放军总医院 

单位级别:

三甲 

Institution
hospital:

Chinese People's Liberation Army (PLA) General Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

东方肝胆外科医院 

单位级别:

三甲 

Institution
hospital:

Eastern hepatobiliary surgery hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

生物学应答

指标类型:

主要指标 

Outcome:

Biochemical response

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

病毒学应答

指标类型:

主要指标 

Outcome:

Virological response

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:

无病生存期

指标类型:

次要指标 

Outcome:

disease-free survival

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:

肿瘤

组织:

Sample Name:

tumor tissue

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

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:

标本中文名:

尿液

组织:

Sample Name:

urine

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 70 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):

无随机分组

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

No randomization

盲法:

N/A

Blinding:

N/A

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):

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

None

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:

本研究采用的是病历记录表(CRF)

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

This clinical trial uses a CRF (Case Record Form,CRF)

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-06-25
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