Background/Objectives: Systemic treatment for unresectable hepatocellular carcinoma (HCC) has rapidly advanced, with immune checkpoint inhibitors now the preferred first-line option. However, with multiple agents available and no established treatment sequence, selecting the most suitable second-line (2L) therapy remains challenging. While sorafenib is frequently chosen for 2L treatment, comprehensive data supporting its use is limited. This study evaluates the effectiveness of sorafenib as 2L therapy and factors influencing outcomes following first-line treatment failure in advanced HCC patients. Methods: This is a retrospective, multicenter study, including 81 patients with unresectable HCC from 12 European centers who received sorafenib as 2L treatment. Median overall survival (mOS), median progression-free survival (mPFS), radiological response to treatment, and toxicity were evaluated. Univariable and multivariable analyses were performed to identify potential predictors of clinical benefit. Results: In this cohort, some patients were treated with 2L sorafenib mOS for 7.4 months (95% CI: 6.6–13.6) and other patients were treated with mPFS for 3.7 months (95% CI: 3.0–4.8). Multivariable analysis revealed the best median OS for patients with CP A and AFP levels < 400 ng/mL (15.5 months). Adverse events (AE) of grade ≥ 3 were reported in 59.4% of patients. Conclusions: In this real-world cohort of European patients with unresectable HCC, the outcome of sorafenib treatment in the 2L setting was comparable to that of the other established 2L treatment options in patients with preserved liver function and good performance status. This study contributes to the understanding of the role of sorafenib in the 2L setting and underscores the need for further research to identify predictive factors for response and survival in order to optimize treatment algorithms for advanced HCC.
背景/目的：对于不可切除肝细胞癌（HCC）的系统治疗已迅速发展，免疫检查点抑制剂现已成为首选一线治疗方案。然而，由于多种药物可用且尚无确定的治疗顺序，选择最合适的二线（2L）治疗仍具挑战性。虽然索拉非尼常被选作二线治疗，但支持其应用的综合数据有限。本研究评估了索拉非尼作为二线治疗的有效性，以及影响晚期HCC患者一线治疗失败后结局的因素。方法：这是一项回顾性、多中心研究，纳入了来自12个欧洲中心的81例接受索拉非尼作为二线治疗的不可切除HCC患者。评估指标包括中位总生存期（mOS）、中位无进展生存期（mPFS）、影像学治疗反应及毒性。通过单变量和多变量分析确定临床获益的潜在预测因素。结果：在该队列中，部分患者接受二线索拉非尼治疗的mOS为7.4个月（95% CI：6.6–13.6），mPFS为3.7个月（95% CI：3.0–4.8）。多变量分析显示，Child-Pugh A级且甲胎蛋白水平<400 ng/mL的患者中位OS最佳（15.5个月）。59.4%的患者报告了≥3级不良事件。结论：在这项针对欧洲不可切除HCC患者的真实世界队列研究中，对于肝功能保留且体能状态良好的患者，索拉非尼在二线治疗中的疗效与其他已确立的二线治疗方案相当。本研究有助于理解索拉非尼在二线治疗中的作用，并强调需要进一步研究以确定治疗反应和生存的预测因素，从而优化晚期HCC的治疗策略。
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