Arsenic Trioxide Combined With DEB-TACE In The Treatment Of Huge Hepatocellular Carcinomas:A Clinical Study

Objective:To evaluate the safety and efficacy of Arsenic trioxide combined with DEB-TACE in the treatment of huge hepatocellular carcinomas,and to analyze the factors affecting the treatment response and survival time.Methods:This study was a single-center prospective study.From January 2018 to June 2019,60 patients with huge hepatocellular carcinomas were expected to be enrolled in our medical center according to the inclusion criteria and exclusion criteria.Before the operation,clinical characteristics and preoperative laboratory indicators of the patients were recorded in detail,and all patients received arsenic trioxide combined with DEB-TACE.All postoperative adverse events were recorded in the follow-up,and relevant postoperative laboratory indicators were recorded.CT/MRI examination was performed to evaluate postoperative lesion progression.The end point of follow-up was lesion progression or death.Treatment response was assessed according to the mRECIST,and safety was assessed according to the changes of relevant laboratory indicators and postoperative adverse events before and after surgery.Kaplan-Meier curve was used to analyze PFS and OS,and Logistic regression model and Cox proportional risk regression model were used to analyze the factors affecting treatment response and survival time.Results:1.The 60th patient was enrolled in March 2019,the last follow-up time was February 1,2021,for all the patients,median follow-up time was 29.8±3.8 months.During the follow-up period,7 patients were withdrawn from the study with treatments other than DEB-TACE,and 10 patients were lost to follow-up.Results:The final analysis of safety,efficacy,and prognostic factors in this study included 43 patients with huge hepatocellular carcinomas.2.One month after the first DEB-TACE,the rates of CR,PR,ORR and DCR were 6.98%,67.44%,74.42%and 90.7%.The blood routine,liver and kidney function related indexes of the patients became significantly worse 1 week after surgery,and most of them recovered 1 to 3 months after surgery.Pain and fever were the most common postoperative adverse reactions.Recent complications occurred in 2 out of all patients,including 1 case of hepatapostema,which was recovered after treatment,and only one patient developed hepatic impairment.No serious adverse events occurred.3.Kaplan-Meier curve analysis of PFS and OS showed that the median PFS was 10.0 months(95%CI:8.4 to 11.5 months)and the median OS was 13.0 months(95%CI:9.9 to 16.0 months).Multivariate Logistic regression model showed that single tumor and tumor capsule were independent protective factors for CR,and portal vein invasion was an independent risk factor for CR in patients with huge hepatocellular carcinomas.According to Cox proportional hazards model,the result is tumor size≥15cm,tumor number>1 and portal vein invasion were independent predictors of decreased OS in patients with huge hepatocellular carcinomas.Conclusions:Arsenic trioxide combined with DEB-TACE in the Treatment of huge hepatocellular carcinomas is safe and effective.Single tumor and tumor capsule were independent protective factors for CR,and PVTT was an independent hazard factor for CR in patients with huge hepatocellular carcinomas.Tumor nodule diameter≥15cm,tumor number>1 and portal vein tumor thrombus(PVTT)were independent predictors of decreased OS in patients with huge hepatocellular carcinomas.