本研究比较了Lenvatinib和程序性细胞死亡蛋白（PD-1）与仅使用Lenvatinib治疗基于改良固体肿瘤反应评估标准标准的晚期肝细胞癌（Ad-HCC）难治型肝动脉灌注化疗（HAIC）的疗效和安全性。从2016年4月至2021年9月，两名放射科医师筛选出145名符合改良固体肿瘤反应评估标准标准的Ad-HCC患者，分为HAIC-lenvatinib组（H-L，n= 87）和HAIC-lenvatinib-PD-1组（H-L-P，n= 58）。我们采用倾向性评分匹配方法来减少选择性偏差。采用Kaplan-Meier分析和对数秩检验比较总体生存率（OS）和进展后无进展生存率（PPS）。采用前向逐步Cox回归模型评估独立预后因子的多变量分析。倾向性评分匹配1：1后，H-L-P组的中位OS为43.6个月，显著长于H-L组（18.9个月）（p=0.009）。H-L-P组的中位PPS为35.6个月，显著长于H-L组（9.4个月）（p=0.009）。多元分析表明，对OS显着影响的因素是 α-fetoprotein（风险比[HR]，2.14；95％CI，1.26-3.98；p=0.006）、对HAIC的早期反应（HR，0.44；95％CI，1.20-3.85；p=0.009）和H-L治疗（HR，0.52；95％CI，0.30-0.86；p=0.012）。修正后的蛋白/胆红素级别（HR，1.32；95％CI，1.03-1.70；p=0.026）、对HAIC的早期反应（HR，0.44；95％CI，0.25-0.77；p=0.004）和H-L（HR，0.47；95％CI，0.28-0.78；p=0.003）显著影响PPS。PD-1抑制剂与Lenvatinib的联合治疗在管理HAIC难治性Ad-HCC患者的生存好处方面具有前途。Lenvatinib加程序性细胞死亡蛋白1抑制剂是一种有效且安全的进展后治疗，相对于仅使用Lenvatinib治疗的患者，它显著改善了总体生存率和进展后无进展生存率。 ©2023美国癌症协会。

This study compares the efficacy and safety of lenvatinib and programmed cell death protein (PD)-1 versus lenvatinib alone for advanced hepatocellular carcinoma (Ad-HCC) refractory to hepatic arterial infusion chemotherapy (HAIC).From April 2016 to September 2021, 145 patients with Ad-HCC refractory to HAIC based on modified Response Evaluation Criteria in Solid Tumors criteria were enrolled by two radiologists and classified into the HAIC-lenvatinib group (H-L, n = 87) and HAIC-lenvatinib-PD-1 group (H-L-P, n = 58). A propensity score-matching method was used to reduce selective bias. The overall survival (OS) and postprogression-free survival (PPS) rates were compared using the Kaplan-Meier method with log-rank test. Multivariable analyses of independent prognostic factors were evaluated by means of the forward stepwise Cox regression model.After propensity score matching 1:1, the median OS was 43.6 months in the H-L-P group and was significantly longer than that (18.9 months) of the H-L group (p = .009). The median PPS was 35.6 months in the H-L-P group and was significantly longer than that (9.4 months) of the H-L group (p = .009). Multivariate analyses showed that the factors that ‎significantly affected the OS were‎ α-fetoprotein (hazard ratio [HR], 2.14; 95% CI, 1.26-3.98; p = .006), early response to HAIC (HR, 0.44; 95% CI, 1.20-3.85; p = .009), and H-L treatment (HR, ‎0.52; 95% CI, 0.30-0.86; p = .012). Modified albumin-bilirubin grade (HR, 1.32; 95% CI, 1.03-1.70; p = .026), early response to HAIC (HR, 0.44; 95% CI, 0.25-0.77; p = .004), and H-L (HR, ‎0.47‎; 95% CI, 0.28-0.78; p = .003) significantly affected the PPS.This combination therapy of PD-1 inhibitors plus lenvatinib has promising survival benefits in the management of patients with Ad-HCC refractory to HAIC.Lenvatinib plus programmed death 1 inhibitor is an effective and safe postprogression treatment and improved significantly overall survival and postprogression-free survival compared with lenvatinib alone in patients with advanced hepatocellular carcinoma refractory to hepatic arterial infusion chemotherapy.© 2023 American Cancer Society.