仑伐替尼对肝细胞癌患者的疗效及安全性分析

肝癌电子杂志 ›› 2025, Vol. 12 ›› Issue (3): 1-6.

• 论著 • 下一篇

仑伐替尼对肝细胞癌患者的疗效及安全性分析

周健国¹, 王炳忱¹, 李昊城², 张跃伟³, 彭涛⁴, 刘红利⁵, 项晓军⁶, 孙传东⁷, 刘军⁸, 栗光明⁹, 李德卫¹⁰, 王瑜¹⁰, 蔡建强^1,*

1.国家癌症中心/国家肿瘤临床医学研究中心/中国医学科学院北京协和医学院肿瘤医院肝胆外科,北京 100021;
2.神州医疗科技股份有限公司,北京 100089;北京清华长庚医院肝胆介入科,北京 102218;
4.广西医科大学第一附属医院肝胆外科,广西南宁 530021;
5.华中科技大学同济医学院附属协和医院肿瘤中心,湖北武汉 430022;
6.南昌大学第一附属医院肿瘤科,江西南昌 330006;
7.青岛大学附属医院肝胆胰外科,山东青岛 266003;
8.山东第一医科大学附属省立医院器官移植肝胆外二科,山东济南 250022;
9.首都医科大学附属北京佑安医院普通外科,北京 100069;
10.重庆大学附属肿瘤医院肝胆胰肿瘤中心,重庆 400030

收稿日期:2025-06-04 出版日期:2025-09-30 发布日期:2025-11-03
通讯作者: ^*蔡建强,E-mail：caijianqiang@cicams.ac.cn
基金资助:
齐智华夏-白求恩·原发性肝癌专项研究基金（QL-HCC-RWS-1）; 基于个体化精准测评的肝癌系统治疗策略研究国家科技重大专项(项目号 2024ZD0520500）

Efficacy and safety of lenvatinib in patients with hepatocellular carcinoma

Zhou Jianguo¹, Wang Bingchen¹, Li Haocheng², Zhang Yuewei³, Peng Tao⁴, Liu Hongli⁵, Xiang Xiaojun⁶, Sun Chuandong⁷, Liu Jun⁸, Li Guangming⁹, Li Dewei¹⁰, Wang Yu¹⁰, Cai Jianqiang^1,*

1. Department of Hepatobiliary Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China;
2. Digital Health China Technologies Co., LTD, Beijing 100089, China;
3. Department of Hepatobiliary Intervention, Beijing Tsinghua Changgung Hospital, Beijing 102218, China;
4. Department of Hepatobiliary Surgery, The First Affiliated Hospital, Guangxi Medical University, Nanning 530021 , Guangxi,, China;
5. Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, Hubei, China;
6. Department of Oncology, The First Affiliated Hospital, Nanchang University, Nanchang 330006, Jiangxi, China;
7. Department of Hepatobiliary and Pancreatic Surgery, Affiliated Hospital of Qingdao University, Qingdao 266003, Shandong, China;
8. Department of Liver Transplantation and Hepatobiliary Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250022, Shandong, China;
9. Department of General Surgery Center, Beijing You'an Hospital, Capital Medical University, Beijing 100069, China;
10. Department of Hepatobiliary and Pancreatic Tumor Center, Cancer Hospital Affiliated to Chongqing University, Chongqing 400030, China

Received:2025-06-04 Online:2025-09-30 Published:2025-11-03
Contact: ^* Cai Jianqiang, E-mail: caijianqiang@cicams.ac.cn

摘要/Abstract

摘要： 目的: 评价以仑伐替尼为基础的综合治疗方案在肝细胞癌（HCC）患者中的疗效及安全性。
方法: 回顾性分析2022年1月至2024年12月全国13家研究中心收治的1 000例接受仑伐替尼为基础的综合治疗的HCC患者。HCC患者基本临床信息、治疗方案、实验室指标及生存结局均通过标准化数据库进行收集和管理。研究的主要终点为无进展生存（PFS）,次要终点为总生存（OS）及安全性分析。采用Kaplan-Meier生存分析及log-rank检验评估不同治疗策略的疗效差异。
结果: 1000例HCC患者中男性占比83.70%,中位年龄为59.0岁（IQR：52.0,67.0）。高血压占比最高（15.60%）,其次为糖尿病（5.80%）和肝硬化（5.00%）。既往接受过手术治疗的占比30.50%,肝切除占比19.50%,仅1.80%患者接受过放射治疗,介入治疗应用率为34.60%。乙型肝炎病毒表面抗原阳性率为55.10%,抗丙型肝炎病毒抗体阳性率为3.80%。晚期（巴塞罗那分期C、D期）患者占比28.00%。在治疗方案方面,79.80%患者接受8 mg仑伐替尼治疗,60.7%患者接受仑伐替尼单药治疗,20.8%患者接受仑伐替尼联合免疫治疗。疗效分析显示全组患者中位PFS时间为7.0个月（95%CI为7.0~8.0个月）,1年OS率为97.00%(95%CI为96.00%~98.00%);1年PFS率为16.00%(95%CI为14.00%~19.00%)。随访期间不良事件发生率为23.60%,未观察到严重不良事件。
结论: 仑伐替尼联合策略对HCC患者预后有积极影响,但现有数据不足以推断长期结局,仍需延长随访加以验证。

关键词: 肝细胞癌, 仑伐替尼, 免疫治疗, 预后

Abstract: Objective: To evaluate the efficacy and safety of the comprehensive treatment regimen based on lenvatinib in patients with HCC.
Methods: This study was a retrospective real-world study. A total of 1,000 HCC patients who received comprehensive treatment based on lenvatinib and were admitted to 13 research centers across the country from January 2022 to December 2024 were included. The basic clinical information of patients, treatment plans, laboratory indicators and survival outcomes were all collected and managed through standardized databases. The primary endpoint of the study was progression-free survival (PFS), and the secondary endpoints included the 1-year PFS rate, 1-year overall survival rate (OS), and safety analysis. Statistical analysis was conducted using Kaplan-Meier survival analysis and log-rank test to evaluate the differences in efficacy among different treatment strategies.
Results: Among 1 000 patients, 83.70% were male, and the median age was 59.0 years (IQR: 52.0, 67.0). In the analysis of the combined disease history of the patients, the disease distribution showed significant differences: The proportion of history of hypertension was the highest (15.60%), followed by history of diabetes (5.80%), and liver cirrhosis (5.00%). The proportion of patients who had received surgical treatment in the past was 30.50%, the proportion of liver resection was 19.50%, and only 1.80% of the patients had received radiotherapy. The application rate of interventional therapy in the population of this study was 34.60%. The positive rate of hepatitis B virus surface antigen was 55.10% and the positive rate of anti-hepatitis C virus antibody was 3.80%. According to the Barcelona Clinic Liver Cancer(BCLC) staging, the proportion of patients in the advanced stage (BCLC-C, D stage) was 28.00%. In terms of treatment regimens, 79.80% of the patients received 8mg lenvatinib treatment, 60.7% of the patients received lenvatinib monotherapy, and 20.8% of the patients received combined immunotherapy. The therapeutic effect analysis showed that the median PFS of the overall patients was 7.0 months (95%CI: 7.0-8.0), and the 1-year OS rate was 97.00%(95%CI: 96.00%-98.00%). The 1-year PFS rate was 16.00%(95%CI: 14.00%-19.00%). The adverse events occurred rate was 23.60% during the follow-up period, and no serious adverse events were observed.
Conclusion: The lenvatinib combination strategy has a positive impact on survival prognosis for HCC patients, but it still needs to be optimized for long-term disease control.

Key words: Hepatocellular carcinoma, Lenvatinib, Immunotherapy, Prognosis

周健国, 王炳忱, 李昊城, 张跃伟, 彭涛, 刘红利, 项晓军, 孙传东, 刘军, 栗光明, 李德卫, 王瑜, 蔡建强. 仑伐替尼对肝细胞癌患者的疗效及安全性分析[J]. 肝癌电子杂志, 2025, 12(3): 1-6.

Zhou Jianguo, Wang Bingchen, Li Haocheng, Zhang Yuewei, Peng Tao, Liu Hongli, Xiang Xiaojun, Sun Chuandong, Liu Jun, Li Guangming, Li Dewei, Wang Yu, Cai Jianqiang. Efficacy and safety of lenvatinib in patients with hepatocellular carcinoma[J]. Electronic Journal of Liver Tumor, 2025, 12(3): 1-6.

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仑伐替尼对肝细胞癌患者的疗效及安全性分析

Efficacy and safety of lenvatinib in patients with hepatocellular carcinoma

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