Electronic Journal of Liver Tumor ›› 2025, Vol. 12 ›› Issue (3): 1-6.

• Original article •     Next Articles

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 Jianqiang1,*   

  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

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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