本研究旨在探讨TACE联合Lenvatinib和PD-1阻断治疗HCC合并门静脉癌栓（PVTT）的有效性和安全性。 HCC合并PVTT患者接受TACE联合Lenvatinib和PD-1阻断作为回顾性纳入临床实践中的一线治疗。所有受试者均定期随访以获得预后结果。收集并记录联合治疗期间观察到的安全性概况。采用Logrank检验探索性分析预后和基线特征，采用Cox回归分析进行多因素分析。 本研究共纳入67例接受TACE联合乐伐替尼和PD-1阻断的患有PVTT的HCC患者。治疗期间的最佳治疗反应为：4名患者达到完全缓解，30名患者显示部分缓解，25名患者疾病稳定，5名患者疾病进展，3名患者不可用。该方案的客观缓解率为50.7%[95%置信区间(CI)：38.2-63.2%]，疾病控制率为88.1%(95% CI:77.8-94.7%)。接受 TACE 联合乐伐替尼和 PD-1 阻断的 67 名患有 PVTT 的 HCC 患者的中位无进展生存期为 9.3 个月（95% CI：5.85-12.75），中位总生存期为 24.4 个月（95% CI：19.11） -29.69）。安全性概况显示，65名患者在治疗期间出现了无论级别如何的不良反应（97.0%），其中34名患者被视为≥3级不良反应（50.7%）。最常见的不良反应是高血压、疲劳、肝功能异常、恶心、呕吐和腹泻。总体不良反应是可接受且可控的。TACE 联合乐伐替尼和 PD-1 阻断作为 PVTT 肝细胞癌的一线治疗显示出潜在的可行性和令人鼓舞的临床结果，为 HCC 患者提供长期生存获益。这一结论应在前瞻性大规模临床试验中得到证实。© 2024 Sun et al.

This study aimed to investigate the feasibility of the efficacy and safety of TACE combined with Lenvatinib and PD-1 blockade in HCC with portal vein tumor thrombus (PVTT).Patients with HCC and PVTT who underwent TACE combined with Lenvatinib and PD-1 blockade as first-line therapy in clinical practice were retrospectively included. All subjects were followed-up regularly to obtain prognostic outcomes. The safety profile observed during the combination therapy was collected and documented. The Log rank test was used for exploratory analysis of prognosis and baseline characteristics and Cox regression analysis was used for multivariate analysis.A total of 67 HCC patients with PVTT who received TACE combined with Lenvatinib and PD-1 blockade were included in this study. The best therapeutic response during treatment suggested that 4 patients achieved complete response, 30 patients showed partial response, 25 patients were stable disease, 5 patients had disease progression and 3 patients were not available. Objective response rate of this regimen was 50.7% [95% confidence interval (CI): 38.2-63.2%] and disease control rate was 88.1% (95% CI: 77.8-94.7%). The median progression-free survival of 67 HCC patients with PVTT who received TACE combined with Lenvatinib and PD-1 blockades was 9.3 months (95% CI: 5.85-12.75), and the median overall survival was 24.4 months (95% CI: 19.11-29.69). The safety profile highlighted that 65 patients experienced adverse reactions regardless of grade during treatment (97.0%), among whom 34 patients were deemed as grade ≥3 adverse reactions (50.7%). The most common adverse reactions were hypertension, fatigue, abnormal liver function, nausea, vomiting, and diarrhea. Overall adverse reactions were acceptable and controllable.TACE combined with Lenvatinib and PD-1 blockades as first-line therapy for HCC with PVTT demonstrated potential feasibility and encouraging clinical outcomes, providing long-term survival benefits for HCC patients. This conclusion should be confirmed in prospective large-scale clinical trials.© 2024 Sun et al.