目的：探讨仑伐替尼和国产程序性细胞死亡受体-1（PD-1）抑制剂卡瑞利珠单抗联合肝动脉化疗栓塞术（TACE）治疗晚期或不可切除肝细胞癌患者的临床疗效及安全性。方法：回顾性分析2019年1月至2021年6月南京市第二医院接受仑伐替尼和卡瑞利珠单抗联合（LPT组，44例）或不联合（LP组，28例） TACE治疗的72例晚期或不可切除肝细胞癌患者的临床资料，统计相关不良反应发生情况，比较两组疗效及生存情况。结果：中位随访时间为11.5个月。LPT组的客观缓解率（ORR）为40.9%，高于LP组（17.9%，P=0.041），LPT组疾病控制率（DCR）为79.5%，高于LP组（53.6%，P=0.020）。LPT组中位总生存时间（OS）为15.7个月，平均OS为13.6个月，LP组中位OS为9.7个月，平均OS为9.2个月，两组OS比较差异有统计学意义（P=0.005，HR=0.36，95%CI 0.17~0.76）。LPT组中位疾病进展时间（TTP）为13.00个月，平均TTP为12.14个月，LP组中位TTP为8.6个月，平均TTP为8.42个月，两组TTP比较差异有统计学意义（P=0.016，HR=0.43，95%CI 0.22~0.87）。72例患者均产生了不同程度的不良反应，但均为轻中度和可控的。结论：仑伐替尼和卡瑞利珠单抗联合TACE显示了优于仑伐替尼联合卡瑞利珠单抗的疗效，不良反应可耐受，推荐一线用于晚期或不可切除的肝细胞肝癌。

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