Abstract：
Aims/Background The combination of lenvatinib and programmed cell death protein 1 (PD-1) inhibitor has demonstrated significant efficacy in treating unresectable hepatocellular carcinoma. Our study aimed to evaluate the safety and efficacy of triple therapy that includes hepatic arterial infusion chemotherapy, lenvatinib and PD-1 inhibitor for treating unresectable hepatocellular carcinoma. Methods Patients with a primary diagnosis of advanced hepatocellular carcinoma between June 2020 and August 2023 were included in this study. Initially, 53 patients with hepatocellular carcinoma were enrolled. Then, 13 patients were excluded based on the inclusion criteria, resulting in 40 patients included for analysis. Among them, 31 patients received triple therapy, including 16 Barcelona Clinic Liver Cancer C stage, 12 Barcelona Clinic Liver Cancer-B, and 3 Barcelona Clinic Liver Cancer-A hepatocellular carcinoma patients. The primary endpoint was the objective response rate, while the secondary endpoints included the conversion resection rate, pathological complete response rate, pathological partial response rate, and treatment-related adverse events. Results The objective response rate was 80.65% at a median follow-up of 24.5 months (range: 12.6-55.8 months). Of the 14 patients (45.2%) who underwent conversion therapy and were eligible for surgery, 7 patients underwent liver resection and the remaining 7 patients underwent liver transplantation. The median interval between the start of triple therapy and surgery was 117 days, ranging from 25 to 215 days. The pathological complete response was observed in six patients (19.4%) and the pathological partial response rate in eight patients (25.8%). All adverse events occurred in 77.4% of the patients. Conclusion In patients with unresectable hepatocellular carcinoma, the combination of hepatic arterial infusion chemotherapy, lenvatinib, and PD-1 inhibitor exhibits favourable efficacy and well tolerability, achieving a desirable pathological complete response rate while maintaining manageable drug toxicity.
摘要：
目的/背景lenvatinib和程序性细胞死亡蛋白1（PD-1）抑制剂的组合已证明在治疗不可切除的肝细胞癌中具有显着的疗效。我们的研究旨在评估三联疗法的安全性和有效性，包括肝动脉灌注化疗，乐伐替尼和PD-1抑制剂治疗不可切除的肝细胞癌。方法本研究纳入2020年6月至2023年8月原发性诊断为晚期肝细胞癌的患者。最初，纳入53例肝细胞癌患者。然后，根据纳入标准排除了13例患者，结果40例患者纳入分析。其中,31例患者接受三联疗法，包括16巴塞罗那诊所肝癌C期，12巴塞罗那诊所肝癌-B，和3巴塞罗那诊所肝癌-A肝细胞癌患者。主要终点是客观反应率，而次要终点包括转换切除率，病理完全缓解率，病理部分反应率，和治疗相关的不良事件。结果中位随访24.5个月（范围：12.6-55.8个月），客观缓解率为80.65％。在接受转换治疗并符合手术条件的14例患者（45.2％）中，7例患者行肝切除术，其余7例患者行肝移植。三联疗法开始和手术之间的中位间隔为117天，从25到215天不等。病理完全缓解6例(19.4%)，病理部分缓解8例(25.8%)。所有不良事件发生在77.4%的患者中。结论在不可切除的肝细胞癌患者中,联合肝动脉灌注化疗，lenvatinib,PD-1抑制剂表现出良好的疗效和良好的耐受性，达到理想的病理完全缓解率，同时保持可控的药物毒性。
