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：	ChiCTR2400091597
最近更新日期： Date of Last Refreshed on：	2024-10-30 23:32:55
注册时间： Date of Registration：	2024-10-30 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	介入联合靶向和免疫治疗在具有高危复发因素的CNLC分期IB-IIa肝癌患者新辅助治疗疗效评估
Public title：	Evaluation of the efficacy of interventional combination of targeted and immunotherapy in neoadjuvant therapy in patients with CNLC stage IB-IIa liver cancer with high-risk recurrence factors
注册题目简写：
English Acronym：
研究课题的正式科学名称：	TACE和/或HAIC联合靶向和免疫治疗在具有高危复发因素的CNLC分期IB-IIa肝癌患者新辅助治疗疗效评估的单臂、前瞻性研究
Scientific title：	A Single-arm, Prospective Study of the Efficacy Evaluation of TACE and/or HAIC in Combination With Targeted and Immunotherapy in Patients With CNLC-Stage IB-IIa HCC With High-Risk Recurrence Factors
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：	柯经鹏	研究负责人：	李志民
Applicant：	Jingpeng Ke	Study leader：	Zhimin Li
申请注册联系人电话： Applicant telephone：	+86 156 0693 4515	研究负责人电话： Study leader's telephone：	+86 189 0600 2496
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：	kejingpeng@126.com	研究负责人电子邮件： Study leader's E-mail：	lizhimin@sina.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：	福建省厦门市思明区镇海路55号	研究负责人通讯地址：	福建省厦门市思明区镇海路55号
Applicant address：	No. 55, Zhenhai Road, Siming District, Xiamen City, Fujian Province	Study leader's address：	No. 55, Zhenhai Road, Siming District, Xiamen City, Fujian Province
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：	厦门大学附属第一医院
Applicant's institution：	The First Affiliated Hospital of Xiamen University
研究负责人所在单位：	厦门大学附属第一医院
Affiliation of the Leader：	The First Affiliated Hospital of Xiamen 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：	[2024]科研伦审字 (133)号	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：	厦门大学附属第一医院临床研究伦理委员会
Name of the ethic committee：	Clinical Research Ethics Committee of the First Affiliated Hospital of Xiamen University
伦理委员会批准日期： Date of approved by ethic committee：	2024-09-05 00:00:00
伦理委员会联系人：	郑建玮
Contact Name of the ethic committee：	Jianwei Zheng
伦理委员会联系地址：	厦门市镇海路55号厦门大学附属第一医院临床研究伦理委员会
Contact Address of the ethic committee：	Clinical Research Ethics Committee of the First Affiliated Hospital of Xiamen University, No. 55 Zhenhai Road, Xiamen City
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 592 213 7569	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：

厦门大学附属第一医院

Primary sponsor：

The First Affiliated Hospital of Xiamen University

研究实施负责（组长）单位地址：

福建省厦门市思明区镇海路55号

Primary sponsor's address：

No. 55, Zhenhai Road, Siming District, Xiamen City, Fujian Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中华人民共和国	省(直辖市)：	福建	市(区县)：	厦门
Country：	China	Province：	Fujian	City：	Xiamen
单位(医院)：	厦门大学附属第一医院	具体地址：	福建省厦门市思明区镇海路55号
Institution hospital：	The First Affiliated Hospital of Xiamen University	Address：	No. 55, Zhenhai Road, Siming District, Xiamen City, Fujian Province

经费或物资来源：

无

Source(s) of funding：

Not

研究疾病：

肝癌

Target disease：

Liver Cancer

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：

评估TACE和/或HAIC联合靶向和免疫治疗在具有高危复发因素的 CNLC 分期 IB-IIa 肝癌患者新辅助衔接手术后的无进展生存期

Objectives of Study：

To assess progression-free survival after neoadjuvant articulation in patients with CNLC-stage IB-IIa HCC with high-risk recurrence factors in combination with targeted and immunotherapy

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. Voluntarily sign the informed consent form; 
2. Age ≥ 18 years old and ≤ 80 years old, male or female; 
3. Meet the clinical diagnostic criteria of the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2024 Edition) or be pathological Patients with histologically or cytologically confirmed hepatocellular carcinoma (HCC) and assessed as acceptable Patients undergoing surgery (ablation, liver resection, liver transplantation);
 4. Clinical staging of liver cancer in China (CNLC): IB-IIA; Assessed by the investigator to have an adjacent liver large ducts (arteries, veins, bile ducts) with visceral access, no capsule, and suspicious on imaging possible high-risk factors such as foci or microvascular metastases; 
5. Subjects must have at least one measurable lesion according to mRECIST criteria;
 6. Tumor burden ≤ 60%; 
7. Child-Pugh score of liver function≤7 points; 
8. United States Eastern Cooperative Oncology Group (ECOG) score ≤1; 
9. Expected survival time≥3 months; 
10. No previous anti-tumor therapy, including liver local therapy and systemic therapy; 
11. Blood routine and liver and kidney function meet the following requirements (no blood transfusion, no human albumin injection, and no correction treatment with cytokine drugs such as G-CSF within 14 days before screening): Hemoglobin (HB) ≥ 90 g/L; Absolute neutrophil count (ANC) ≥ 1.5×109/L; White blood cell count (WBC) ≥ 3.0×109/L and < 15×109/L; Platelets (PLT) ≥75×109/L; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <5× upper limit of normal (ULN); Total bilirubin (TBiL) ≤ 34.2 μmol/L; Albumin (ALB) >30 g/L; Serum creatinine (Cr) ≤ 1.5×ULN or muscle calculated according to the Cockcroft-Gault formula Anhydride clearance (CrCL) ≥ 50 mL/min;  Activated partial thromboplastin time (APTT) ≤ 1.5×ULN, while the international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5×ULN; 
12. For women who are not postmenopausal (non-treatment-induced amenorrhea for ≥12 months) or who have not undergone surgical sterilization (removal of ovaries and/or uterus): agree to remain abstinent or use a single or combined contraceptive method with an annual failure rate of 1% for the duration of treatment and for at least 6 months after the last dose. 
13. Male patients must agree to use a highly effective method of contraception for the duration of the study and for 6 months after the last administration of study drug.

排除标准：

1. 确诊 HCC 后，既往接受过手术、局部治疗或全身抗肿瘤治疗的患者; 2. 肝癌累及左右两侧肝叶或经诊断为弥漫性肝癌; 3. 肝癌侵犯胆道或引起胆道梗阻; 4. 有区域淋巴结或肝外转移的患者，或合并肝癌以外的恶性肿瘤; 5. 存在门脉主干癌栓; 6. 有血管造影和选择性肝脏导管插入术禁忌症，或对造影剂、麻醉剂、镇静剂严重过敏或不耐受; 7. 已知或疑似对任何与研究相关的药物过敏; 8. 肝动脉灌注显像提示胃肠道分流，或存在其他肝外侧支肿瘤血供，且均无法通过血管介入技术纠正; 9. 门静脉高压伴腹水或筛选期前 6 个月内有胃底静脉曲张出血史; 10. 严重肺功能不全(FEV1/FVC<50%，或最大通气量 MVV<50 L/min)，或既往有间质性肺病病史; 11. 胆管系统功能不全、既往胆道介入治疗或肝胰壶腹(Vater 壶腹)受损; 12. 活动性感染，包括结核(临床诊断包括临床病史、体格检查和影像学发现，以及根据当地医疗常规进行的结核病检查)、乙型肝炎(HBsAg 阳性且 HBV DNA 检测值超过 1000 cps/mL 或 500 IU/mL)或丙型肝炎(HCV 抗体阳性且 HCV 病毒滴度检测值超过正常值上限); 13. HIV 阳性或获得性免疫缺陷综合征(AIDS)患者; 14. 存在任何活动性、已知或可疑的自身免疫性疾病患者; 15. 严重心律失常或心力衰竭病史; 16. 妊娠期和哺乳期妇女; 17. 入组前 30 天内参与其他临床试验(观察性、非干预性研究除外); 18. 其它研究者认为不适合参与本研究的情况；

Exclusion criteria：

1. Patients who have received prior surgery, local therapy, or systemic anti-tumor therapy after the diagnosis of HCC; 2. Liver cancer involving the left and right lobes of the liver or diffuse liver cancer is diagnosed; 3. Liver cancer invades the biliary tract or causes biliary obstruction; 4. Patients with regional lymph nodes or extrahepatic metastases, or malignant tumors other than liver cancer; 5. Presence of portal trunk cancer thrombus; 6. Have contraindications to angiography and selective liver catheterization, or have a strong appetite for contrast agents, anesthetics, severe allergy or intolerance to sedatives; 7. Known or suspected allergy to any study-related medications; 8. Hepatic arterial perfusion scintigraphy suggests gastrointestinal shunt, or the presence of other lateral hepatic branches blood supply to the tumor, all of which cannot be corrected by vascular interventional techniques; 9. Portal hypertension with ascites or history of gastric variceal bleeding within 6 months prior to the screening period; 10. Severe pulmonary insufficiency (FEV1/FVC<50%, or maximum ventilation MVV<50 L/min), or a prior history of interstitial lung disease; 11. Biliary system insufficiency, previous biliary intervention, or hepatopancreatic ampulla (Vater ampulla). Injure; 12. Active infection, including tuberculosis (clinical diagnosis includes clinical history, physical examination, and imaging finding, as well as tuberculosis testing according to local medical practice), hepatitis B (HBsAg positive and HBV DNA test values greater than 1000 cps/mL or 500 IU/mL), or hepatitis C (HCV antibody positive and HCV viral titer test values above the upper limit of normal); 13. HIV-positive or acquired immunodeficiency syndrome (AIDS) patients; 14. Presence of any active, known or suspected autoimmune disease; 15. History of severe cardiac arrhythmia or heart failure; 16. Pregnant and lactating women; 17. Participation in other clinical trials within 30 days prior to enrollment (except observational, non-interventional studies); 18. Other situations that the investigator considers unsuitable to participate in this study

研究实施时间：

Study execute time：

从 From 2024-11-01 00:00:00至 To 2027-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2024-11-01 00:00:00 至 To 2026-10-31 00:00:00

干预措施：

Interventions：

组别：	干预组	样本量：	61
Group：	Intervention group	Sample size：	61
干预措施：	肝癌外科手术前进行介入联合靶向免疫治疗2周期	干预措施代码：	61
Intervention：	Before surgery for liver cancer, interventional combined targeted immunotherapy was performed for 2 cycles	Intervention code：	61

研究实施地点：

Countries of recruitment and research settings：

国家：	中华人民共和国	省(直辖市)：	福建	市(区县)：
Country：	China	Province：	Fujian	City：
单位(医院)：	厦门大学附属第一医院	单位级别：	三甲
Institution hospital：	The First Affiliated Hospital of Xiamen University	Level of the institution：	Tertiary A

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	Type：	Primary 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：

正在进行

Recruiting

年龄范围：

Participant age：

最小 Min age		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:

公开/Public

盲法：
Blinding：
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

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）：	无
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：	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
数据与安全监察委员会： Data and Safety Monitoring Committee：	暂未确定/Not yet
注册人： Name of Registration：	2024-10-30 23:32:28