[A retrospective controlled study of TACE-HAIC-targeted-immune quadruple therapy for intermediate and advanced-stage hepatocellular carcinoma].

Objective: To evaluate the efficacy and safety of transcatheter arterial chemoembolization (TACE)-hepatic arterial infusion chemotherapy (HAIC)-targeted-immune quadruple therapy in patients with intermediate and advanced-stage hepatocellular carcinoma (HCC). Methods: 101 patients with intermediate and advanced stage HCC were enrolled according to the inclusion and exclusion criteria, and then they were divided into a combination group and a control group. Patients in the combination group was treated with TACE-HAIC-targeted-immune quadruple therapy, while the control group was only treated with TACE therapy. The overall survival (OS), progression-free survival (PFS), and treatment-related adverse reactions were statistically analyzed in the two groups of patients. Statistical analysis was carried out by t-test, χ2 test, rank sum test, Kaplan-Meier curve, log-rank test, Cox regression (or proportional hazards model) analysis according to different data. Results: The tumor objective response rate and disease control rate as evaluated by mRECIST 1.1 criteria in the combination group were 80% and 94%, respectively, which were significantly higher than those in the control group, 41.2% (P<0.001) and 74.5% (P=0.007). The OS and PFS of the combination group were 15.6 months [95%CI 11.3-NA ] and 8.8 months [95%CI 6.9-12.0], respectively, which were significantly better than the control group at 6.1 months [95%CI 5.3-6.6] (P<0.001) and 3.2 months [95%CI 3.0-3.6] (P<0.001). Gastric ulcer incidence was significantly higher in the combination group (9/50, 18%) than that in the control group (2/51, 3.9%) (P=0.023). Conclusion TACE-HAIC-targeted-immune quadruple therapy is a more effective treatment mode for intermediate and advanced-stage HCC than TACE alone, and attention should be paid to the monitoring of target immune-related adverse reactions.目的： 评价经导管动脉化疗栓塞术（TACE）-肝动脉灌注化疗（HAIC）-靶向-免疫四联治疗中晚期肝细胞癌（HCC）患者的疗效和安全性。 方法： 根据入排标准入组101例中晚期HCC患者，分为联合组和对照组。联合组患者行TACE-HAIC-靶向-免疫四联治疗，对照组患者仅接受TACE治疗。对2组患者的总生存期（OS）、无疾病进展生存期（PFS）、治疗相关的不良反应进行统计分析。据资料不同采用t检验、χ2检验、秩和检验、Kaplan-Meier曲线、对数秩检验、Cox回归分析或Cox比例风险模型分析进行统计学分析。 结果： 以mRECIST 1.1标准评估联合组肿瘤客观缓解率和疾病控制率分别为80%和94%，明显高于对照组的41.2%（P<0.001）和74.5%（P=0.007）。联合组的OS和PFS为15.6（95%CI 11.3～NA）个月和8.8（95%CI 6.9～12.0）个月，明显优于对照组的6.1（95%CI 5.3～6.6）个月（P<0.001）和3.2（95%CI 3.0～3.6）个月（P<0.001）。联合组胃溃疡发生率（9/50，18%）比对照组（2/51，3.9%）明显增加（P=0.023）。 结论： TACE-HAIC-靶向-免疫四联治疗对比单纯TACE治疗是一种更有效的中晚期HCC治疗方式，需注意对靶免治疗相关不良反应的监测。.