肝脏 ›› 2024, Vol. 29 ›› Issue (12): 1480-1483.

• 肝癌 • 上一篇    下一篇

信迪利单抗联合仑伐替尼治疗晚期原发性肝癌的疗效和安全性分析

田昳程, 唐祖雄, 汝干, 王奇, 翟春涛   

  1. 215000 江苏 苏州科技城医院(田昳程,汝干,王奇,翟春涛);苏州大学附属第一医院(唐祖雄)
  • 收稿日期:2024-06-22 出版日期:2024-12-31 发布日期:2025-02-19
  • 通讯作者: 翟春涛

An analysis on the efficacy and safety of sintilimab combined with lenvatinib in the treatment of advanced hepatocellular carcinoma

TIAN Yi-cheng1, TANG Zu-xiong2, RU Gan1, WANG Qi1, ZHAI Chun-tao1   

  1. 1. Suzhou Science&Technology Town Hospital, Jiangsu 215000, China;
    2.The First Affiliated Hospital of Soochow University,Jiangsu 215000,China
  • Received:2024-06-22 Online:2024-12-31 Published:2025-02-19
  • Contact: ZHAI Chun-tao

摘要: 目的 分析信迪利单抗联合仑伐替尼治疗晚期原发性肝癌(HCC)的疗效及安全性。方法 收集2021年1月至2023年12月苏州科技城医院和苏州大学附属第一医院收治的68例晚期HCC患者的临床资料。对照组34例患者接受仑伐替尼单药治疗,观察组34例患者接受信迪利单抗联合仑伐替尼治疗。评估患者生命体征和实验室结果直到死亡、失去联系或研究结束,采用实体肿瘤疗效评价标准(mRECIST)评估抗肿瘤反应,绘制生存曲线,记录治疗期间不良事件发生情况。结果 两组患者基线临床资料和治疗期间不良事件发生情况比较,差异均无统计学意义(P>0.05)。观察组中位无进展生存期(PFS)为11.5个月,对照组为6.8个月,差异有统计学意义(P=0.013,HR=0.568,95% CI:0.359~0.886)。观察组中位总生存期(OS)为21.5个月,对照组为12.7个月,差异有统计学意义(P=0.005,HR=0.426,95% CI:0.237~0.782)。治疗后观察组患者客观缓解率(ORR)和疾病控制率(DCR)分别为44.12%和85.29%,对照组患者分别为23.53%和58.82%,差异有统计学意义(P<0.05)。结论 信迪利单抗联合仑伐替尼治疗晚期HCC安全有效,比仑伐替尼单药治疗具有更好的长期预后。

关键词: 原发性肝癌, 信迪利单抗, 仑伐替尼, 疗效, 安全性

Abstract: Objective To analyze the efficacy and security of sintilimab combined with lenvatinib in the treatment of advanced hepatocellular carcinoma (HCC).Methods A total of 68 patients with advanced HCC were selected from January 2021 to December 2023 as the research subjects. Thirty-four patients in the control group received lenvatinib monotherapy, and 34 patients in the observation group received sintilimab combined with lenvatinib treatment. Patients' vital signs and clinical laboratory results were continuously evaluated until they died, lost contact, or the study was ended. The antitumour response was assessed using the HCC specific modified RECIST (mRECIST), the survival curves were plotted and the occurrence of adverse events during treatment was recorded.Results There were no significant differences in the baseline clinical data and the occurrence of adverse events during treatment between the two groups (P>0.05). The median PFS were 11.5 months and 6.8 months in two groups, with significant difference (P=0.013, HR=0.568, 95%CI=0.359-0.886). The median OS were 21.5 months and 12.7 months in two groups, with significant difference (P=0.005, HR=0.426, 95%CI=0.237-0.782). After treatment, the ORR and DCR were 44.12% and 85.29%, respectively, in the observation group, and were 23.53% and 58.82% in the control group, with significant differences (P<0.05).Conclusion Sintilimab combined with lenvatinib is effective and safe in the treatment of advanced HCC and may lead to a better long-term outcome than lenvatinib monotherapy.

Key words: Hepatocellular carcinoma, Sintilimab, Lenvatinib, Efficacy, Security