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经肝动脉灌注化疗联合卡瑞利珠单抗栓塞术治疗HCC有效性和安全性临床研究
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注册号:

Registration number:

ChiCTR2000033353 

最近更新日期:

Date of Last Refreshed on:

2020-05-29 

注册时间:

Date of Registration:

2020-05-29 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

经肝动脉灌注化疗联合卡瑞利珠单抗栓塞术治疗HCC有效性和安全性临床研究 

Public title:

A study on the efficacy and safety of transcather arterial infusion chemotherapy combined with camrelizumab followed embolization in the treatment of HCC 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

经肝动脉灌注化疗联合卡瑞利珠单抗栓塞术治疗原发性肝细胞癌的有效性和安全性临床研究 

Scientific title:

A study on the efficacy and safety of transcather arterial infusion chemotherapy combined with camrelizumab followed embolization in the treatment of primary 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:

冯威健 

研究负责人:

冯威健 

Applicant:

Feng Weijian 

Study leader:

Feng Weijian 

申请注册联系人电话:

Applicant telephone:

+86 15633597772 

研究负责人电话:

Study leader's telephone:

+86 15633597772 

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:

13910579666@139.com 

研究负责人电子邮件:

Study leader's E-mail:

13910579666@139.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:

河北石家庄市裕华区仓丰路48号 

研究负责人通讯地址:

河北石家庄市裕华区仓丰路48号 

Applicant address:

48 Cangfeng Road, Yuhua District, Shijiazhuang, Hebei 

Study leader's address:

48 Cangfeng Road, Yuhua District, Shijiazhuang, Hebei 

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:

石家庄平安医院 

Applicant's institution:

Shijiazhuang Ping'an 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:

2020001 

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:

石家庄平安医院医学伦理委员会 

Name of the ethic committee:

Ethics Committee of Shijiazhuang Ping'an Hospital  

伦理委员会批准日期:

Date of approved by ethic committee:

2020-05-26 

伦理委员会联系人:

吴维海 

Contact Name of the ethic committee:

Wu Weihai 

伦理委员会联系地址:

河北石家庄市裕华区仓丰路48号 

Contact Address of the ethic committee:

48 Cangfeng Road, Yuhua District, Shijiazhuang, Hebei 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 0311-67802263 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

sjzpayykjk@yeah.net 

研究实施负责(组长)单位:

石家庄平安医院 

Primary sponsor:

Shijiazhuang Ping'an Hospital 

研究实施负责(组长)单位地址:

河北石家庄市裕华区仓丰路48号 

Primary sponsor's address:

48 Cangfeng Road, Yuhua District, Shijiazhuang, Hebei 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

河北

市(区县):

石家庄

Country:

China

Province:

Hebei

City:

Shijiazhuang

单位(医院):

石家庄平安医院

具体地址:

裕华区仓丰路48号

Institution
hospital:

Shijiazhuang Ping'an Hospital

Address:

48 Cangfeng Road, Yuhua District

经费或物资来源:

自筹 

Source(s) of funding:

Self-financing 

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:

探索性研究/预试验 

Study phase:

研究目的:

评估经肝动脉灌注化疗联合卡瑞利珠单抗栓塞术治疗原发性肝细胞癌的有效性和安全性。 

Objectives of Study:

The purpose of this study is to assess efficacy and safety of patients who received transcather arterial infusion chemotherapy combined with camrelizumab followed embolization in HCC. 

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:18-75岁; 2. 经 CT/MRI、肿瘤标志物(AFP) 联合检测临床确诊或术前穿刺病理确诊的原发性肝细胞癌; 3. CNLC IIb、IIIa和部分IIIb期,至少有一个以上可测量病灶(根据RECIST1.1标准),病灶达到中度以上动脉血供; 4. 无手术切除指征,或患者拒绝手术; 5. 门静脉主干未完全阻塞,或虽完全阻塞但门静脉代偿性侧支血管丰富或通过门静脉支架植入可以复通门静脉血流; 6. Child-Pugh A或B级; 7. ECOG PS评分:0-2分; 8. 预计生存期≥12周; 9. 主要器官功能正常,即符合下列标准: (1)血常规检查: a)HB≥80 g/L; b)WBC≥3.0×10^9/L; c)ANC≥1.5×10^9/L; d)PLT≥50×10^9/L; (2)生化检查: a)ALB ≥30g/L; b)ALT和AST<5ULN; c)TBIL ≤3ULN; d)肌酐 ≤1.5ULN; 10. 左室射血分数≥50%; 11. 育龄妇女须在入组前14天内进行妊娠试验(血清或尿液)结果为阴性,且自愿在观察期间和末次给予研究药物后8周内采用适当的方法避孕;对于男性,应为手术绝育或同意在观察期间和末次给予研究药物后8周内采用适当方法避孕; 12. 受试者自愿加入本研究,签署知情同意书,依从性好,配合随访。 

Inclusion criteria

1. Aged 18 to 75 years; 2. Primary hepatocelluar carcinoma comfired by CT/MRI and tumor marker(AFR) combined detection or diagnosed by preoperative puncture pathology; 3. CNLC IIb IIIa and part of IIIb,at least one measurable lesion (according to RECIST 1.1),the lesion reaches a moderate or higher arterial blood supply; 4. No indication of surgical resection or rejection of surgery; 5. The main portal vein is not completely obstructed, or although it is completely obstructed, the compensated collateral vessels of the portal vein are abundant or implanted through the portal vein stent can restore portal vein blood flow; 6. Chlid-Pugh A or B; 7. ECOG PS 0-2; 8. Expected survival period >= 12 weeks 9.The main organs function normally ,met the following criteria (1) Blood routine examination a) HB >= 80 g/L b) WBC >= 3.0 x 10^9/L c)ANC >= 1.5 x 10^9/L d)PLT >= 50 x 10^9/L (2) Biochemical examination a) ALB >= 30g/L b) ALT和AST<5ULN c) TBIL <= 3ULN d) plasma Cr <= 1.5ULN 10. Left ventriculaor ejection fraction(LVEF)normal low limit(50%) 11.Women of childbearing age must have contraceptive measures or have test pregnancy (serum or urine) enroll the study before 14 days, and the results must be negative, and take the methods of contraception during the test and the last to have drugs after 8 weeks. Men must be contraception or has sterilization surgery during the test and the last to have drugs after 8 weeks; 12. Participants voluntarily joined the clinical trial,signed the informed consent,good adhereence,and were well-adhereed to follow. 

排除标准:

1. 无法纠正的凝血功能障碍; 2. 合并活动性肝炎或严重感染且不能同时治疗者;允许慢性乙型肝炎患者经抗病毒治疗,病毒(HBV)载量低于2000IU/mL或丙型肝炎病毒(HCV)感染患者入组; 3. 恶液质或多器官衰竭者; 4. 肿瘤占全肝体积的比例≥70%(如果肝功能基本正常,可考虑采用少量碘油乳剂和颗粒性栓塞剂分次栓塞); 5. 对于外周血白细胞和血小板显著减少,白细胞<3.0×109/L,血小板<50×109/L非绝对禁忌,如脾功能亢进者,排除化疗性骨髓抑制; 6. 用药前14天之内使用过免疫抑制药物,不包括喷鼻和吸入性皮质类固醇或生理剂量的系统性类固醇激素(即不超过10 mg/天强的松龙或同等药物生理学剂量的其他皮质类固醇); 7. 5年内患有其他恶性肿瘤的患者(已经治愈的皮肤基底细胞癌和宫颈原位癌除外); 8. 人类免疫缺陷病毒(HIV)感染或已知有获得性免疫缺陷综合征(艾滋病); 9. 用药前6个月内,出现以下情况:心肌梗死、严重/不稳定型心绞痛、NYHA 2级以上心功能不全、控制不良的心律失常(包括QTcF间期男性>450 ms,女性>470 ms,QTcF间期以Fridericia公式计算)、症状性充血性心力衰竭、脑血管意外(包括一过性脑缺血发作或症状性肺栓塞); 10. 已知异体器官移植史或异体造血干细胞移植史; 11. 首次给药前4周内参与过任何其他药物临床研究; 12. 已知有精神类药物滥用且无法戒除或精神障碍的; 13. 研究者认为不适合参与本研究的患者。 

Exclusion criteria:

1. Uncorrectable coagulopathy; 2. Patients with active hepatitis or severe infection who cannot be treated at the same time; patients with chronic hepatitis B are allowed to undergo antiviral treatment, viral (HBV) load is less than 2000IU / mL or patients infected with hepatitis C virus (HCV) are included; 3. Cachexia or multiple organ failure 4. The proportion of the tumor to the total liver volume is >= 70% (if the liver function is basically normal, a small amount of iodized oil emulsion and granular embolization agent may be considered for fractional embolization) 5. For peripheral blood leukocytes and platelets significantly reduced, leukocytes < 3.0 x 10^9 / L, platelets < 50 x 10^9 / L are not absolute contraindications, such as hypersplenism, chemotherapy-induced bone marrow suppression is excluded; 6. Have used immunosuppressive drugs within 14 days before adminstration,dose not include nosel and inhaled corticosteriods or physiological dose of systemic steriod hormones(no more than 10 mg / day of prednisolone or other corticosteroids of equivalent pharmaceutical physiological dose); 7. Patients with other malignancies within 5 years (except for cured skin basal cell carcinoma and cervical carcinoma in situ); 8. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); 9. 6 months before study drug administration, the following occurred: myocardial infarction, severe / unstable angina pectoris, grade III-IV cardiac insufficiency according to New York Heart Association (NYHA) criteria, uncontrolled arrhythmias (including QTcF interval male> 450 ms, female > 470 ms ,The QTcF interval is calculated using Fridericia formula), symptomatic congestive heart failure, cerebrovascular accidents (including transient ischemic attack or symptomatic pulmonary embolism), in stable phase, need a cardiovascular physician evaluation; 10. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 11. Less than 4 weeks from the last clinical trial; 12. Known to be abused by psychotropic substances and unable to quit or mental disorders; 13. The researchers think inappropriate. 

研究实施时间:

Study execute time:

From2020-06-01To 2023-05-31 

干预措施:

Interventions:

组别:

试验组

样本量:

30

Group:

Experimental Group

Sample size:

干预措施:

卡瑞利珠单抗

干预措施代码:

Intervention:

camrelizumab

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

河北 

市(区县):

石家庄 

Country:

China 

Province:

Hebei 

City:

Shijiazhuang 

单位(医院):

石家庄平安医院 

单位级别:

三级 

Institution
hospital:

Shijiazhuang Ping'an Hospital  

Level of the institution:

Tertiary 

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 (PFS)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

客观缓解率

指标类型:

次要指标 

Outcome:

Objective Response Rate (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:

疾病控制率

指标类型:

次要指标 

Outcome:

Disease Control Rate (DCR)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

总生存期

指标类型:

次要指标 

Outcome:

Overal Survival (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:

安全性

指标类型:

次要指标 

Outcome:

safty

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

5年

Fate of sample:

Destruction after use 

Note:

5years

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 15 years
最大 Max age 75 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):

未使用

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

Not used

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

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

Articles published

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:

无/No

注册人:

Name of Registration:

 2020-05-29
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