Clinical Retrospective Analysis Of TACE Combined With Lenvatinib Mesylate And Sintilimab In The Treatment Of Unresectable Hepatocellular Carcinoma

Objective: To investigate the efficacy,safety and prognosis of transcatheter arterial chemoembolization(TACE)combined with lenvatinib mesylate and sintilimab in the treatment of unresectable hepatocellular carcinoma(HCC).Materials and methods:A retrospective analysis was carried out in the Department of Hepatobiliary Surgery of Hebei People’s Hospital who received TACE combined with lenvatinib mesylate + sindilimab from January 1,2020 to July 31,2022,and finally 65 cases with complete data information were included after screening,and Response Evaluation Criteria in Solid Tumours(m RECIST)criterion was used to divide whether the diameter of the cancer lesion was ≥reduced by 30% into effective group(n=46)and invalid group(n=19).The following test indicators were selected to analyze the factors affecting the prognosis of the included patients: sex,age,hypertension,diabetes,history of hepatitis,cirrhosis,smoking history,alcohol history,BMI,presence or absence of antiviral therapy,portal vein cancer thrombus(PVTT),BCLC tumor stage,preoperative AFP level,preoperative Child grade,preoperative albumin,preoperative albumin,albumin/globulin preoperative neutrophils/lymphocytes,with or without surgery,3 months after TACE AFP,Carcinoembryonic antigen before medication,CA199 before medication,ferritin level before medication,tumor diameter.Associated adverse reactions that occurred during combination therapy were recorded.In this study,SPSS25.0 software was used for processing and analysis.The statistically significant(P<0.05)in univariate analysis was included in the multivariate analysis to analyze the independent influencing factors.The survival curve was plotted by the Kaplan-Meier method,and the median PFS and median OS were calculated.COX multivariate regression analysis predicts the influencing factors of PFS and OS in HCC combination therapy patients.A bilateral P-value < 0.05 is considered significant.The effects on the efficacy,OS and PFS prognosis of combination therapy were recorded.Results: A total of 65 HCC patients treated with TCAE combined with lenvatinib mesylate + sindilimab were included,and the efficacy was evaluated according to m RECIST criteria,and 46 cases were objectively effective,with an incidence rate of 73.85%(46/65).All HCC patients who underwent TACE had some degree of post-embolic syndrome after surgery,which improved after treatment and were not independently recorded.Univariate analysis of multiple variables in the effective group(n=46)and inactive group(n=19)of combination therapy showed that HCC history,PVTT,tumor diameter,BCLC tumor stage,number of TACEs,CA199,AFP3 months after TACE surgery,and P<0.05 of the number of cancer foci.The variables P<0.05 in univariate analysis were analyzed for binary logistic regression,and the history of previous HCC surgery(P=0.014),the number of cancer foci(P=0.003),and the BCLC tumor stage(P=0.024)were independent influencing factors affecting the ORR of combination therapy.According to the m RECIST criteria,the CR was 20%,the PR was 53.85%,the ORR was 73.85%,the DCR was 80%,the median PFS was 12.046(95%CI: 10.47～13.62),and the median OS was 18.846(95% CI: 13.046～16.38).Throughout the combination therapy period,60(92.3%)patients experienced adverse reactions associated with systemic therapy.Survival analysis of the variable P<0.05 in univariate analysis showed that previous HCC surgery history was an independent protective factor for combination therapy with PFS,while the number of cancer foci was an independent risk factor for PFS.Previous HCC surgery history and AFP 3 months after TACE surgery were independent protective factors affecting the prognosis of OS,while BCLC tumor stage was an independent risk factor for combination therapy.Conclusion: 1.The results of multivariate analysis suggested that the history of HCC surgery,the number of cancer foci,and the stage of BCLC were independent factors affecting ORR in combination therapy.Previous history of HCC was an independent protective factor for PFS in combination therapy,and the number of cancer foci was an independent risk factor for PFS in combination therapy.Previous history of HCC surgery and AFP 3months after operation were independent protective factors affecting the prognosis of OS after combined treatment,and independent risk factors for OS after combined treatment of BCLC tumor stage.The combined treatment effect of patients with a history of HCC surgery is better than that of patients without a history of HCC surgery,which reflects the early detection,diagnosis and treatment of HCC,which has certain clinical significance for the prognosis of patients.2.For patients with a history of HCC,postoperative recurrence and no further surgical treatment,TACE combined with Renvatinib mesylate and sindilizumab may achieve clinical complete remission in some patients.3.Although 92.3% of patients experienced adverse reactions during the entire treatment of HCC with TACE combined with Renvastinib mesylate and sindilizumab,symptoms could be gradually alleviated after symptomatic treatment or dose reduction.4.TACE combined with Renvastinib mesylate and sindilizumab significantly prolonged PFS and OS in unresectable HCC patients with recurrence after radical surgery.However,this study was a single-arm,small sample clinical retrospective study,and its findings need to be verified by multi-center,prospective randomized controlled trials.