| ObjectiveTo evaluate the clinical efficacy and safety of FOLFOX regimen of hepatic artery infusion chemotherapy combined with PD-1 inhibitor and sorafenib for the treatment of intermediate unresectable intermediate to advanced hepatocellular carcinoma by comparing TACE in combination with sorafenib regimen.MethodsRetrospective analysis of 112 patients with intermediate to advanced hepatocellular carcinoma in the Third Hospital of Guangzhou Medical University from September 2019 to January 2023,with HAIC combined with PD-1 inhibitor and sorafenib in the treatment group;and TACE combined with sorafenib in the control group.The differences in clinical efficacy and safety between the two groups were compared.Kaplan-Meier was used to calculate the median progression-free survival time(PFS)and overall survival time(OS)to draw survival curves.Tumor response was evaluated according to the mRECIST criteria,and treatment-related adverse effects were recorded.ResultsA total of 55 patients were included in the treatment group study and 57 patients were included in the control group.The differences in baseline characteristics between the two groups were not significant(all P>0.05).1.PFS and OS time were better in the treatment group than in the control group,Median PFS: 9.52 months vs.5.64 months,P=0.001;Median OS: not reached vs.9.33 months,P<0.001.2.According to mRECIST criteria: objective remission rate(ORR: 56.4% vs.35.1%,P=0.036)and disease control rate(DCR: 80.0% vs.50.9%,P=0.001)were significantly better in the treatment group than in the control group.3.Multivariate regression analysis showed that treatment regimen and distant metastasis were independent risk factors for PFS.Treatment regimen,portal vein carcinoma embolism,and extrahepatic metastasis were independent risk factors for OS.4.Subgroup analysis: When extrahepatic metastases were present,PFS and OS were not statistically significant in the treatment group versus the control group.When portal vein cancer thrombosis was present,OS was prolonged in the treatment group compared with the control group,which was statistically significant.5.No treatment-related grade 5 adverse events occurred in either group.Two grade 4 adverse events of immune hepatitis occurred in the treatment group.ConclusionsCompared with TACE combined with sorafenib,HAIC combined with PD-1inhibitors and sorafenib significantly prolonged progression-free survival time,improved objective remission rate and disease control rate in patients with intermediate to advanced hepatocellular carcinoma,with relatively controllable adverse effects and good safety. |