| Objective:In this study,TACE combined RFA with or without apatinib were used to treat patients with advanced hepatocellular carcinoma.Between the two groups,the short-term efficacy,long-term survival rate and adverse reactions were compared to explore the safety,efficacy and mechanism of TACE combined with RFA and apatinib in the treatment of advanced hepatocellular carcinoma in order to provide new ideas for the treatment of advanced hepatocellular carcinoma.Methods:This study was a single-center prospective randomized controlled clinical trial,started in May 2015,recruiting advanced hepatocellular carcinoma patients treated in the first affiliated hospital of kunming medical university,and all the patients were randomly divided into two groups:patients in the control group were accepted TACE and RFA treatment,and in the study group,patients were treated by TACE combined with RFA and apatinib.All patients met the inclusion criteria and signed the informed consent of the treatment,and the study was in accordance with the ethics of Helsinki.After treatment,the patient’s physical signs and laboratory index changes were closely monitored.Regular follow-up was conducted after discharge,abdominal enhancement CT or MR imaging examinations were first reviewed to evaluate local efficacy a month after discharge.After that,rechecking every 2 or 3 months to determine whether TACE or RFA should be treated again.The first TACE treatment was the starting point and the end of the follow-up was February 1,2018.The clinical data of patients were statistically analyzed,and the imaging responses,time to progression,overall survival and adverse events of the two groups were compared.SPSS21.0 software was used for statistical analysis,and P<0.05 indicated that the difference was statistically significant.Results:By February 2016,a total of 65 cases of advanced hepatocellular carcinoma had been enrolled in the study,33 cases and 32 cases in the study group and control group respectively.The ORR of the study group was 87.9%and 84.4%in the control group in the first month after the operation.The difference was not statistically significant.(χ2=0.167,P=0.733).The mTTP of the study group was 18 months(95%CI:14.426-21.574 months),and of the control group was 12 months(95%CI:7.712～16.288 months),and the difference was statistically significant(χ2=12.850,P=0.000).The mOS of the study group was 27 months(95%CI:22.767～31.233 months),and of the control group was 20 months(95%CI:15.258～24.742 months),and the difference was statistically significant(χ2=4.973,P=0.026).The 1-year and 2-year survival rate was 81.82%and 51.52%in the study group and was 71.8%and 43.75%in the control group respectively,and the difference was not statistically significant(P<0.05).The independent-prognosis factor with the overall survival of advanced hepatocellular carcinoma relates to the BCLC stage and with or without aoatinib treatment.Whether developed the secondary hypertension and albuminuria after apatinib treatment may be the important factors for the overall survival.The incidence of secondary hypertension,hand-foot skin reaction,oral mucositis,secondary albuminuria and diarrhea were significantly higher than those in the control group,and the difference was statistically significant.After apatinib treatment,the incidence of Ⅲ grand adverse reactions was 15.15%,and the adverse reactions can be tolerated after adjusting the medication.Conclusions:1.TACE combined with RFA and apatinib treatment can prolong the time to progression and overall survival in treating advanced hepatocellular carcinoma;2.The independent-prognosis factor with the overall survival of advanced hepatocellular carcinoma relates to the BCLC stage and with or without aoatinib treatment;3.TACE combined with RFA and apatinib for the treatment of advanced hepatocellular carcinoma have a certain safety;4.Whether occured secondary hypertension and albuminuria after apatinib treatment may be a factor affecting the overall survival time of patients. |
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