大多数肝内胆管癌（ICC）患者表现为局部晚期或转移性疾病。我们报告了TACE（经动脉化疗栓塞）、来那度胺和PD-1抑制剂联合应用在晚期和转移性ICC患者中的综合疗效。该回顾性研究纳入了2017年1月至2021年8月间32名晚期或转移性ICC患者。符合条件的患者在任何治疗线路中接受过基于静脉注射吉西他滨的TACE联合来那度胺，且可以加用PD-1抑制剂。采用Kaplan-Meier方法评估总体生存期（OS）和无进展生存期（PFS）。使用单变量和多变量Cox回归分析评估与OS相关的危险因素。18名患者接受TACE和来那度胺的联合治疗（TL组），14名患者接受TACE、来那度胺和PD-1抑制剂的联合治疗（TLP组）。中位随访时间为19.8个月（范围1.8-37.8）。中位OS为25.3个月（95% CI 18.5-32.1），中位PFS为7.3个月（95% CI 4.9-9.7）。10名患者（31.3%）达到部分缓解，13名（40.6%）病情稳定，疾病控制率为71.9%。 TL组和TLP组的中位OS相似（分别为22.4和27.3个月，危险比率：1.245，95% CI 0.4245-3.653；p=0.687）。回归分析显示，无论治疗组别如何，HBV/HCV感染都是OS的有利独立预测因子（风险比：0.063，95% CI 0.009-0.463；p=0.007）。无与治疗相关的死亡事件，81.3%的研究参与者出现不良事件（AEs），其中大部分为中度程度（71.8%为1-2级）。基于吉西他滨的TACE加来那度胺，可以加用PD-1抑制剂，耐受性良好，并为晚期和转移性ICC患者提供了有希望的治疗效果。TACE、来那度胺或PD-1抑制剂作为单药治疗在晚期和转移性ICC中显示出有限的疗效，本研究提示这些治疗的联合疗效和良好的耐受性。

Most patients with intrahepatic cholangiocarcinoma (ICC) present with locally advanced or metastatic disease. We report the combined potency of transarterial chemoembolization (TACE), lenvatinib and programmed cell death-1 (PD-1) inhibitors in patients with advanced and metastatic ICC.This retrospective study enrolled 32 patients with advanced or metastatic ICC between January 2017 and August 2021. Eligible patients had received gemcitabine-based TACE combined with lenvatinib with or without PD-1 inhibitor in any line of treatment. Overall survival (OS) and progression-free survival (PFS) were estimated using the Kaplan-Meier method. Risk factors associated with OS were assessed using univariate and multivariate Cox regression analyses.Eighteen patients received a combination of TACE and lenvatinib (TL group) and 14 patients received TACE and lenvatinib plus aPD-1 inhibitor (TLP group). The median follow-up time was 19.8 months (range 1.8-37.8). The median OS was 25.3 months (95% CI 18.5-32.1) and the median PFS was 7.3 months (95% CI 4.9-9.7). Partial response was achieved in 10 patients (31.3%), and stable disease in 13 (40.6 %) with disease control rate of 71.9%. The median OS was comparable in the TL and TLP groups (22.4 vs 27.3 months, respectively; hazard ratio: 1.245, 95% CI 0.4245-3.653; p = 0.687). The regression analysis revealed that, regardless of treatment group, a favorable independent prognostic factor for OS was HBV/HCV infection (HR: 0.063, 95% CI 0.009-0.463; p = 0.007). There were no treatment-related deaths and 81.3% of study participants experienced adverse events (AEs), the majority of which were of moderate severity (71.8% Grade 1-2).Gemcitabine-based TACE plus lenvatinib with or without aPD-1 inhibitor was well tolerated and provided promising therapeutic outcomes for patients with advanced and metastatic ICC.Monotherapy with TACE, or Lenvatinib, or PD-1 inhibitors has shown limited efficacy over standard first-line chemotherapy in advanced and metastatic ICC. This work suggested the combined potency of these treatments and well-tolerance.