中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2500112315
最近更新日期： Date of Last Refreshed on：	2025-11-12 15:32:00
注册时间： Date of Registration：	2025-11-12 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	替雷利珠单抗联合仑伐替尼及HAIC新辅助联合替雷利珠单抗辅助治疗用于伴高危复发风险肝细胞癌患者的疗效研究
Public title：	Study on the Efficacy of Tislelizumab Combined With Lenvatinib and HAIC as Neoadjuvant Therapy Followed by Tislelizumab Adjuvant Therapy in Hepatocellular Carcinoma Patients With High Risk of Recurrence
注册题目简写：
English Acronym：
研究课题的正式科学名称：	替雷利珠单抗联合仑伐替尼及HAIC新辅助联合替雷利珠单抗辅助治疗用于伴高危复发风险肝细胞癌患者的疗效研究
Scientific title：	Study on the Efficacy of Tislelizumab Combined With Lenvatinib and HAIC as Neoadjuvant Therapy Followed by Tislelizumab Adjuvant Therapy in Hepatocellular Carcinoma Patients With High Risk of Recurrence
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：	单云峰	研究负责人：	单云峰
Applicant：	yunfeng shan	Study leader：	Shan yunfeng
申请注册联系人电话： Applicant telephone：	+86 138 5776 3998	研究负责人电话： Study leader's telephone：	+86 577 5557 9452
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：	Shanyunfeng@wmu.edu.cn	研究负责人电子邮件： Study leader's E-mail：	Shanyunfeng@wmu.edu.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：	浙江省温州市瓯海区南白象街道	研究负责人通讯地址：	浙江省温州市瓯海区温州医科大学附属第一医院南白象院区
Applicant address：	Nanbaixiang Town, Ouhai District, Wenzhou City	Study leader's address：	The First Affiliated Hospital of Wenzhou Medical University Nanbaixiang Wenzhou
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：	温州医科大学附属第一医院
Applicant's institution：	The First Affiliated Hospital of Wenzhou Medical University
研究负责人所在单位：	温州医科大学附属第一医院
Affiliation of the Leader：	The First Affiliated Hospital of Wenzhou 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：	KY2024-308	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：	温州医科大学附属第一医院临床研究伦理委员会
Name of the ethic committee：	Ethics Committee in Clinical Research (ECCR) of the First Affiliated Hospital of Wenzhou Medical University
伦理委员会批准日期： Date of approved by ethic committee：	2024-12-28 00:00:00
伦理委员会联系人：	黄胜威
Contact Name of the ethic committee：	Shengwei Huang
伦理委员会联系地址：	浙江省温州市瓯海区温州医科大学附属第一医院南白象院区
Contact Address of the ethic committee：	The First Affiliated Hospital of Wenzhou Medical University Nanbaixiang Wenzhou
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 577 5557 8056	伦理委员会联系人邮箱： Contact email of the ethic committee：	huangsw58@163.com

研究实施负责（组长）单位：

温州医科大学附属第一医院

Primary sponsor：

The First Affiliated Hospital of Wenzhou Medical University

研究实施负责（组长）单位地址：

浙江省温州市瓯海区温州医科大学附属第一医院南白象院区

Primary sponsor's address：

The First Affiliated Hospital of Wenzhou Medical University Nanbaixiang Wenzhou

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	浙江省	市(区县)：
Country：	China	Province：	Zhejiang	City：
单位(医院)：	温州医科大学附属第一医院	具体地址：	浙江省温州市瓯海区温州医科大学附属第一医院南白象院区
Institution hospital：	The First Affiliated Hospital of Wenzhou Medical University	Address：	The First Affiliated Hospital of Wenzhou Medical University Nanbaixiang Wenzhou

经费或物资来源：

中关村精准医学基金会

Source(s) of funding：

China zhongguancun Precision Medicine science and technology foundation

研究疾病：

伴高危复发风险肝细胞癌

Target disease：

Hepatocellular carcinoma with high risk of recurrence

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

研究设计：

单臂

Study design：

Single arm

研究目的：

替雷利珠单抗联合仑伐替尼及HAIC新辅助联合替雷利珠单抗辅助治疗用于伴高危复发风险肝细胞癌患者的疗效研究

Objectives of Study：

Efficacy Study of Tislelizumab Combined with Lenvatinib and HAIC as Neoadjuvant Therapy Followed by Tislelizumab as Adjuvant Therapy in Hepatocellular Carcinoma Patients with High Risk of Recurrence

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

1.Patients confirmed by imaging to have hepatocellular carcinoma (HCC);
2.Male or female patients over 18 years old;
3.Child Pugh liver function grade A;
4.HCC patients who have previously received curative treatment (such as surgical resection or liver transplantation) or have not received any treatment for hepatocellular carcinoma;
5.The ECOG (Eastern Collaboration Group Oncology Group) score before the first administration of the study was 0 or 1;
6.Expected survival time is at least 6 months;
7.Before administration, the organ function level meets the requirements and is tolerant to surgery. Important organ functional indicators meet the following requirements: hemoglobin>= 90g/L, neutrophil count>= 1.5 × 10^9/L, platelet count >= 80 × 10^9/L; aspartate transaminase or alanine transaminase <= 5 times the upper limit of normal (ULN), alkaline phosphatase<= 2.5 ULN, serum albumin >= 30g/L; Serum creatinine<1.5 ULN; International normalized ratio (INR) <= 2 or prothrombin time (PT) within the upper limit of normal range <= 6 seconds; Serum creatinine <= 1.5 ULN, creatinine clearance rate >= 60 mL/min;
8.According to the preoperative assessment by researchers, the patient has a high risk of recurrence and meets one or more of the following conditions:   1.Ib: There are 2-3 tumors with a single diameter>5cm and a maximum diameter <= 3cm; IIa: Tumors 2-3, with a maximum diameter greater than 3 centimeters; IIb: More than 4 tumors   2. There is portal vein thrombosis (PVTT), including invasion of small branches of the portal vein (Vp1/Vp2)   3. Imaging shows incomplete tumor capsule;
9.According to RECIST 1.1 criteria, patients must have at least one measurable lesion (lymph node lesion with CT/MRI scan long diameter >= 10mm or CT/MRI scan short diameter >= 15mm, and the lesion has not received radiotherapy, cryotherapy, or other local treatments);
10.Women of childbearing age must use reliable contraceptive methods or undergo pregnancy tests (serum or urine) within 7 days before enrollment, with negative results, and agree to use appropriate contraceptive methods during the trial period and within 8 weeks after the last administration of the study drug. For males, they must agree to use appropriate contraceptive methods or undergo surgical sterilization during the trial period and within 8 weeks after the last administration of the study drug.
11.The patient voluntarily participates in this study and provides a signed informed consent form to cooperate with postoperative follow-up;

排除标准：

1.任何已接受治疗但存在残余肿瘤的患者；
2.原发性肝癌的肝外转移；
3.受试者既往或并发恶性肿瘤；
4.肿瘤负荷>=肝体积50%的弥漫性肝癌;和/或分类为 IV 型的门静脉大血管浸润;和/或下腔静脉肿瘤血栓形成。
5.肝动脉灌注化疗（HAIC）治疗的禁忌症。
6.入组前 3 个月内或目前正在接受溶栓或抗凝治疗的显着临床出血或出血倾向；
7.有自身免疫病史或需要长期服用免疫抑制剂；
8.人类免疫缺陷病毒（HIV）或已知后天免疫缺陷综合征（AIDS）检测呈阳性的历史；
9.有其他因素导致患者无法手术者；
10.存在酒精依赖、精神疾病、怀孕（或哺乳）或其他不适合临床试验的疾病。

Exclusion criteria：

1.Any patient who has received treatment but still has residual tumors;
2.Extrahepatic metastasis of primary liver cancer;
3.Previous or concurrent malignant tumors of the subject;
4.Diffuse liver cancer with tumor burden >= 50% of liver volume; And/or portal vein invasion classified as type IV; And/or thrombosis of inferior vena cava tumors.
5.Contraindications for hepatic arterial infusion chemotherapy (HAIC) treatment.
6.Significant clinical bleeding or bleeding tendency within 3 months prior to enrollment or currently undergoing thrombolytic or anticoagulant therapy;
7.Have a history of autoimmune diseases or require long-term use of immunosuppressants;
8.History of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS);
9.Other factors that prevent patients from undergoing surgery;
10.Existence of alcohol dependence, mental illness, pregnancy (or breastfeeding), or other conditions unsuitable for clinical trials.

研究实施时间：

Study execute time：

从 From 2024-12-01 00:00:00至 To 2028-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-12-01 00:00:00 至 To 2026-10-01 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	40
Group：	Study Group	Sample size：	40
干预措施：	替雷利珠单抗联合仑伐替尼及HAIC新辅助联合替雷利珠单抗辅助治疗	干预措施代码：
Intervention：	Induction therapy using tislelizumab in combination with lenvatinib and HAIC, followed by maintenance tislelizumab monotherapy.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	浙江省	市(区县)：
Country：	China	Province：	Zhejiang	City：
单位(医院)：	温州医科大学附属第一医院	单位级别：	三级甲等
Institution hospital：	The First Affiliated Hospital of Wenzhou Medical University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	1年RFS率	指标类型：	主要指标
Outcome：	1-year recurrence-free survival rate	Type：	Primary indicator
测量时间点：	1年	测量方法：	影像学指标
Measure time point of outcome：	1 year	Measure method：	Imaging indicators

指标中文名：	生存期	指标类型：	次要指标
Outcome：	Overall Survival	Type：	Secondary indicator
测量时间点：	5年	测量方法：	随访
Measure time point of outcome：	5 year	Measure method：	Follow-up

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	无	组织：
Sample Name：	NA	Tissue：
人体标本去向	其它	说明
Fate of sample：	0thers	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	岁 years
最大 Max age		岁 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

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

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：	无
Blinding：	None

是否共享原始数据： IPD sharing	否No
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）：	不共享数据
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Data will not be shared.
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：	数据采集由CRF表进行。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Data collection was performed using CRFs.
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2025-11-12 15:31:23