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A prospective randomized controlled clinical study of the efficacy of lenvatinib combined with TACE versus TACE alone in patients with advanced first-line unresectable hepatitis B infection
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注册号:

Registration number:

ChiCTR2000033343 

最近更新日期:

Date of Last Refreshed on:

2020-07-03 

注册时间:

Date of Registration:

2020-05-28 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

孙军辉医师:请尽快上传伦理审批文件并填写伦理审批日期。 晚期一线不可切除乙肝感染原发性肝癌应用仑伐替尼联合TACE对比单纯TACE疗效对照前瞻性随机对照临床研究 

Public title:

A prospective randomized controlled clinical study of the efficacy of lenvatinib combined with TACE versus TACE alone in patients with advanced first-line unresectable hepatitis B infection 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

晚期一线不可切除乙肝感染原发性肝癌应用仑伐替尼联合TACE对比单纯TACE疗效对照前瞻性随机对照临床研究 

Scientific title:

A prospective randomized controlled clinical study of the efficacy of lenvatinib combined with TACE versus TACE alone in patients with advanced first-line unresectable hepatitis B infection 

研究课题代号(代码):

Study subject ID:

HEPIC2003 

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:

孙军辉 

研究负责人:

聂春晖 

Applicant:

Junhui Sun 

Study leader:

Chunhui Nie 

申请注册联系人电话:

Applicant telephone:

+86 13575725162 

研究负责人电话:

Study leader's telephone:

+86 15990155409 

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:

sunjh121@163.com 

研究负责人电子邮件:

Study leader's E-mail:

sunjh121@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:

杭州市庆春路79号 

研究负责人通讯地址:

杭州市庆春路79号 

Applicant address:

79 Qingchun Road, Hangzhou, Zhejiang, China 

Study leader's address:

79 Qingchun Road, Hangzhou, Zhejiang, 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:

浙江大学附属第一医院 

Applicant's institution:

The First Affiliated Hospital of Zhejiang 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)科研快审第(1462)号 

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:

浙江大学医学院附属第一医院科研伦理委员会 

Name of the ethic committee:

Scientific Research Ethics Committee of the First Affiliated Hospital of Zhejiang University 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

郑敏 

Contact Name of the ethic committee:

Min Zheng 

伦理委员会联系地址:

杭州市庆春路79号 

Contact Address of the ethic committee:

79 Qingchun Road, Hangzhou, Zhejiang, 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:

浙江大学附属第一医院 

Primary sponsor:

The First Affiliated Hospital of Zhejiang University 

研究实施负责(组长)单位地址:

杭州市庆春路79号 

Primary sponsor's address:

79 Qingchun Road, Hangzhou, Zhejiang, 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):

浙江

市(区县):

杭州

Country:

China

Province:

Zhejiang

City:

Hangzhou

单位(医院):

浙江大学附属第一医院

具体地址:

庆春路79号

Institution
hospital:

The First Affiliated Hospital of Zhejiang University

Address:

79 Qingchun Road

经费或物资来源:

患者自费购买药品、医院临床科研经费 

Source(s) of funding:

Patients purchase medicines at their own expense, hospital scientific research funding 

研究疾病:

肝癌 

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:

上市后药物 

Study phase:

研究目的:

观察晚期一线不可切除乙肝感染的原发性肝癌(巴塞罗那临床肝癌分期中期或晚期)患者应用仑伐替尼联合TACE(灌注药物暂拟定为蒽环及铂类药物)对比单纯TACE治疗的疗效。 

Objectives of Study:

The efficacy of primary liver cancer (mid- or late stage of clinical liver cancer in Barcelona) is observed to be non-reprecable hepatitis B infection (in the middle or late stage of clinical liver cancer in Barcelona) compared with the efficacy of simple TACE therapy. 

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. 无索拉非尼、仑伐替尼等靶向药物治疗史、无仑伐替尼过敏史,患者符合并且同意接受仑伐替尼及TACE治疗。 2. 乙肝表面抗原阳性超过3个月。 3. 肝癌不可根治性切除,晚期阶段未接受过其他系统治疗。 4. 年龄>18岁,且<75岁。 5. 血压控制良好(≤150/90 mm Hg)。 6. ECOG评分0-1,体能状况良好。 7. 肝功能Child-Pugh分级A级-B7。 8. 预计生存时间≥6月。 9. 血液、肝、肾功能满足以下条件:(REFLECT入排标准) a) 中性粒细胞计数≥1.5×10^9/L。 b) 血小板计数≥75×10^9/L。 c) 血红蛋白浓度≥8.5g/dL。 d) 血清白蛋白浓度≥2.8g/dL。 e) 胆红素低于正常上限的3倍。 f) AST、ALT低于正常上限的5倍,ALP低于正常上限的4倍。 g) 凝血酶原时间延长不超过正常上限6秒。 h) 肌酐低于正常上限的1.5倍。 

Inclusion criteria

1. The patients who have no history of targeted drug therapy such as sorafenib and lovatinib, and no history of lovatinib allergy agree to receive lovatinib and TACE treatment; 2. Patients with HBsAg positive for more than 3 months; 3. Patients with unresectable liver cancer who have not received other systematic treatment in the late stage; 4. Patients older than 18 and younger than 75; 5. Patients with good blood pressure control (< 150 / 90 mm Hg); 6. The patients with ECoG score 0-1 were in good physical condition; 7. Patients with child Pugh grade a-b7 of liver function; 8. Patients with estimated survival time >= 6 months; 9. The functions of blood, liver and kidney meet the following conditions: (discharge standard) Neutrophil count >= 1.5 x 10^9 / L. Platelet count >= 75 x 10^9 / L. Hemoglobin concentration >= 8.5g/dl. Serum albumin concentration >= 2.8g/dl. Bilirubin is 3 times lower than the normal upper limit. AST and ALT were 5 times lower than the normal upper limit, ALP was 4 times lower than the normal upper limit. The prothrombin time was prolonged within 6 seconds. Creatinine was 1.5 times lower than the normal upper limit. 

排除标准:

1. 肝占位超过50%肝脏体积。 2. 肝癌侵犯门静脉主干或下腔静脉等大血管。 3. 肝癌破裂出血。 4. 肝癌肝外转移者。 5. 既往有肝性脑病、难治性腹水或胃底食管静脉曲张病史。 6. 存在TACE治疗的禁忌症,如门体分流,离肝血流,明显的动脉粥样硬化。 7. 对静脉造影剂过敏。 8. 孕妇或哺乳期妇女或两年内计划生育的受试者。 9. 伴随 HIV、梅毒感染。 10. 同时伴随其它恶性肿瘤或入组前 5 年内患有其它恶性肿瘤。 11. 严重心、肾功能及其他器官功能障碍。 12. 活动性的临床严重感染>2级(NCI-CTC version 4)。 13. 患有精神心理疾病可能影响知情同意。 14. 无法服用口服药。 15. 入组前 12 个月内参与过其他药物临床试验。 

Exclusion criteria:

1. Patients whose liver occupied more than 50% of the liver volume; 2. Patients with liver cancer invading the main portal vein or inferior vena cava; 3. Patients with rupture and bleeding of liver cancer; 4. Patients with extrahepatic metastasis of liver cancer; 5. Patients with previous history of hepatic encephalopathy, refractory ascites or gastroesophageal varices; 6. Patients with contraindications to TACE, such as portosystemic shunt, extrahepatic blood flow, obvious atherosclerosis; 7. Patients who are allergic to intravenous contrast media; 8. Pregnant or lactating women or subjects with family planning within two years; 9. Patients with HIV and syphilis infection; 10. Patients with other malignancies or with other malignancies within 5 years before admission; 11. Patients with severe cardiac, renal and other organ dysfunction; 12. Patients with active clinical severe infection > Level 2 (NCI-CTC version 4); 13. Patients with mental disorders may affect informed consent; 14. Patients unable to take oral medicine; 15. Patients who participated in clinical trials of other drugs within 12 months before admission. 

研究实施时间:

Study execute time:

From2020-06-30To 2023-06-30 

干预措施:

Interventions:

组别:

试验组

样本量:

88

Group:

experimental group

Sample size:

干预措施:

仑伐替尼联合TACE

干预措施代码:

Intervention:

Lenvatinib combined with TACE

Intervention code:

组别:

对照组

样本量:

88

Group:

control group

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:

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejaing 

City:

Hangzhou 

单位(医院):

浙江大学附属第一医院 

单位级别:

三级甲 

Institution
hospital:

The First Affiliated Hospital of Zhejiang University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

治疗至不可TACE时间

指标类型:

主要指标 

Outcome:

TTUP

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

无疾病进展生存率

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:

指标中文名:

总体生存率

指标类型:

次要指标 

Outcome:

OS

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

客观反应率

指标类型:

次要指标 

Outcome:

ORR

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生活质量评估

指标类型:

次要指标 

Outcome:

quality-of-life measurements

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 years
最大 Max age 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):

随机数字表

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

Random number table.

盲法:

开放标签

Blinding:

open-label

试验完成后的统计结果(上传文件):

点击下载

Calculated Results ater
the Study Completed(upload file):

download

原始数据公开时间:

The time of sharing IPD:

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):

浙江大学附属第一医院

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

The First Affiliated Hospital of Zhejiang University

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

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

Case Record Form, CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-05-28
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