TACE联合卡瑞利珠单抗治疗中晚期原发性肝癌患者临床疗效研究

Clinical observation of camrelizumab therapy after TACE in the treatment of patients with advanced primary liver cancer

目的观察采用肝动脉化疗栓塞(TACE)术联合卡瑞利珠单抗治疗中晚期原发性肝癌(PLC)患者的临床效果.方法2018年3月~2021年3月安徽省宿州市第一人民医院收治的中晚期PLC患者116例,采用随机数字表法将其分对照组58例和观察组58例,分别给予TACE治疗或在TACE治疗的基础上给予卡瑞利珠单抗治疗.采用ELISA法检测血清癌胚抗原(CEA)、甲胎蛋白(AFP)和甲胎蛋白异质体(AFP-L3)水平,使用流式细胞仪检测外周血T淋巴细胞亚群.采用Kaplan-Meier法绘制生存曲线,采用Log-Rank检验.结果治疗后,观察组获得完全缓解率、部分缓解率、疾病稳定率、客观缓解率和疾病控制率分别为8.6%、48.3%、29.3%、56.9%和86.2%,而对照组则分别为1.7%、36.2%、31.0%、37.9%(P<0.05)和69.0%(P<0.05);观察组血清甲胎蛋白、甲胎蛋白异质体和癌胚抗原水平分别为(86.5±28.7)ng/mL、(183.7±61.4)ng/mL和(9.1±2.6)ng/mL,显著低于对照组[分别为(185.8±34.9)ng/mL、(270.3±71.5)ng/mL和(25.4±3.6)ng/mL,P<0.05];观察组外周血CD4^(+)细胞百分比和CD4^(+)/CD8^(+)比值分别为(38.6±4.1)%和(1.3±0.2),显著高于对照组[分别为(32.3±3.7)%和(1.1±0.1),P<0.05];截止到随访结束,观察组和对照组生存率分别为64.3%(36/56)和43.9%(25/57,x2=3.618,P=0.045).结论采取TACE联合卡瑞利珠单抗治疗中晚期PLC患者有一定的近期疗效,还需要扩大观察.

Objective The aim of this study was to observe the clinical efficacy of camrelizumab therapy after transhepatic arterial chemoembolization(TACE)in the treatment of patients with advanced primary liver cancer(PLC).Methods A total of 116 patients with advanced PLC were admitted to Suzhou First People's Hospital between March 2018 and March 2021,and randomly divided into control and observation group,with 58 patients in each group.The patients in the control group were treated with TACE,and those in the observation group were treated with TACE and after that the carrierizumab was given for six months to one year.Serum alpha fetoprotein(AFP),alpha fetoprotein heterogeneity-L3(AFP-L3)and carcinoembryonic antigen(CEA)levels were detected by ELISA.The peripheral blood T lymphocyte subsets were determined by FCM.The survival curve was drawn by Kaplan-Meier and compared by Log-Rank test.Results At the end of three month treatment,the complete remission,partial remission,stable disease,objective remission rate and disease control rate in the observation group were 8.6%,48.3%,29.3%,56.9%and 86.2%,much superior to 1.7%,36.2%,31.0%,37.9%(P<0.05)and 69.0%(P<0.05)in the control group;serum AFP,AFP-L3 and CEA were(86.5±28.7)ng/mL,(183.7±61.4)ng/mL and(9.1±2.6)ng/mL,significantly lower than[(185.8±34.9)ng/mL,(270.3±71.5)ng/mL and(25.4±3.6)ng/mL,respectively,P<0.05]in the control;the percentage of peripheral blood CD4^(+)cells and the CD4^(+)/CD8^(+)cell ratio were(38.6±4.1)%and(1.3±0.2),both significantly higher than[(32.3±3.7)%and(1.1±0.1),respectively,P<0.05]in the control;up to the end of two-year follow-up,the survival rate in the observation group with two missed was 64.3%(36/56),much higher than 43.9%(25/57,x 2=3.618,P=0.045)in the control with one missed.Conclusion We recommend the carlizumab therapy after TACE in the treatment of patients with advanced PLC,which needs further clinical investigation.