Abstract: Objective To evaluate the real-world efficacy and safety of mFOLFOX systemic chemotherapy combined with immunotherapy and targeted therapy for unresectable hepatocellular carcinoma （uHCC）. Method The real-world data of 51 patients with uHCC treated by mFOLFOX combined with immunotherapy and targeted therapy in the Hepatobiliary Department of Sun Yat-sen Memorial Hospital from July 2022 to July 2023 were retrospective collected and analyzed. Results According to the preliminary statistics, the objective response rate （ORR） and disease control rate （DCR） under the mRECIST standard were 47.1% and 96.1% respectively; Among them, 21 cases （41.2%） successfully underwent conversion surgery, and 5 cases achieved pCR （23.8%） after surgery. Logistic regression analysis showed that the number of tumors was an independent influencing factor for achieving conversion （OR=11.6, 95% CI：1.28~105.41, P=0.029）, while treatment timing may be an independent clinical factor affecting remission, but there was no statistically significant difference （P=0.054）. The average follow-up time was 6.76 months, and the median OS and PFS were not achieved. The overall incidence of treatment related adverse events （TRAE） was 92.1% and the incidence of level 3~4 TRAE is 33.3%. Conclusion mFOLFOX systemic chemotherapy combined with immunotherapy and targeted therapy can be safely and effectively applied to the treatment of unresectable hepatocellular carcinoma, with a considerable conversion surgery rate.

Key words: FOLFOX, systemic chemotherapy, unresectable hepatocellular carcinoma, conversion surgery

摘要： 目的 初步评估mFOLFOX系统性化疗联合靶向免疫方案应用于不可切除肝细胞癌（uHCC）的真实世界疗效和安全性。方法 回顾性收集并分析2022年7月至2023年7月期间中山大学孙逸仙纪念医院肝胆外科收治的51例应用mFOLFOX联合免疫靶向方案治疗uHCC患者的真实世界数据。结果 初步统计mRECIST标准下客观缓解率（ORR）为47.1%,疾病控制率（DCR）为96.1%;其中21例（41.2%）成功转化手术,术后5例达到pCR（23.8%）。Logistic回归分析显示肿瘤数量是达到转化的独立影响因素（OR=11.6,95%CI：1.28~105.41,P=0.029）,而治疗时机可能是临床上影响缓解的独立因素,但未达到统计学差异（P=0.054）。平均随访时间为6.76个月,中位OS及PFS均未达到。治疗相关不良事件（TRAE）总体发生率为92.1%。其中3~4级TRAE发生率为33.3%。结论 mFOLFOX系统性化疗联合靶向免疫方案可安全有效地应用于不可切除肝癌的治疗,并有可观的转化手术率。

关键词: FOLFOX, 系统性化疗, 不可切除肝癌, 转化手术