首页|期刊导航|解放军医学杂志|氩氦刀冷冻消融与经动脉化疗栓塞联合仑伐替尼治疗不可切除肝细胞癌的疗效与安全性比较

氩氦刀冷冻消融与经动脉化疗栓塞联合仑伐替尼治疗不可切除肝细胞癌的疗效与安全性比较OA

Comparison of efficacy and safety between argon-helium cryoablation combined with lenvatinib and transarterial chemoembolization combined with lenvatinib for unresectable hepatocellular carcinoma

中文摘要英文摘要

目的 比较氩氦刀冷冻消融(CRYO)联合仑伐替尼(LEN)与肝动脉化疗栓塞(TACE)联合LEN治疗不可切除肝细胞癌(uHCC)的疗效及安全性.方法 本研究为回顾性队列研究.纳入2020年5月-2023年3月解放军总医院肝病医学部收治的234例uHCC患者,其中107例接受TACE联合LEN治疗(TACE+LEN组),127例接受CRYO联合LEN治疗(CRYO+LEN组).采用1∶1倾向评分匹配(PSM)平衡基线特征,最终纳入192例患者.研究终点为总生存期(OS)、无进展生存期(PFS)、客观缓解率(ORR)、疾病控制率(DCR)及不良事件(AEs).采用Kaplan-Meier法分析生存差异,Cox回归和LASSO回归筛选独立预后因素.结果 PSM匹配后,两组基线特征均衡(P>0.05).192例中,男178例(92.7%),肝硬化182例(94.8%),Child-Pugh A级149例(77.6%),巴塞罗那分期(BCLC)-C期130例(67.7%).CRYO+LEN组与TACE+LEN组中位OS(24.2个月 vs.22.0个月,HR=1.10,P=0.635)、中位PFS(8.7个月 vs.11.9个月,HR=0.89,P=0.477)、ORR(53.1%vs.53.1%,P=1.000)和DCR(78.1%vs.86.5%,P=0.186)差异均无统计学意义.多因素Cox回归分析显示,乙肝病毒感染(HR=0.231,P=0.014)、Child-Pugh分级(HR=1.757,P=0.017)、肿瘤最大直径(HR=1.908,P=0.003)及后续是否行抗程序性死亡受体1(PD-1)治疗(HR=0.652,P=0.045)是OS的独立影响因素.CRYO+LEN组发生胸腔积液(6.2%vs.0%,P=0.038)和皮肤冻伤(8.3%vs.0%,P=0.011)的比例较高,而TACE+LEN组更易出现腹痛(7.3%vs.0%,P=0.021)和非感染性发热(24%vs.5.2%,P=0.001),其余AEs差异无统计学意义(P>0.05).结论 CRYO+LEN在uHCC治疗中显示出与TACE+LEN相似的临床获益及可控的安全性,可为不适合TACE的患者提供有效的替代治疗方案.

Objective To compare the efficacy and safety of argon-helium cryoablation(CRYO)combined with lenvatinib(LEN)and transarterial chemoembolization(TACE)combined with LEN in the treatment of unresectable hepatocellular carcinoma(uHCC).Methods This was a retrospective cohort study.A total of 234 patients with uHCC admitted to the Hepatology Medical Center of Chinese PLA General Hospital from May 2020 to March 2023 were enrolled,including 107 patients treated with TACE+LEN(TACE+LEN group)and 127 patients treated with CRYO+LEN(CRYO+LEN group).A 1:1 propensity score matching(PSM)was used to balance baseline characteristics,and 192 patients were finally enrolled.Study endpoints included overall survival(OS),progression-free survival(PFS),objective response rate(ORR),disease control rate(DCR),and adverse events(AEs).Survival differences were analyzed using Kaplan-Meier method,and independent prognostic factors were screened using Cox regression and LASSO regression analyses.Results After PSM,baseline characteristics were well balanced between the two groups(P>0.05).Of the 192 patients,178(92.7%)were male,182(94.8%)had liver cirrhosis,149(77.6%)were Child-Pugh class A,and 130(67.7%)were at Barcelona Clinic Liver Cancer(BCLC)stage C.No significant differences were observed between CRYO+LEN and TACE+LEN groups in median OS(24.2 months vs.22.0 months,HR=1.10,P=0.635),median PFS(8.7 months vs.11.9 months,HR=0.89,P=0.477),ORR(53.1%vs.53.1%,P=1.000),or DCR(78.1%vs.86.5%,P=0.186).Multivariate Cox regression analysis identified hepatitis B virus(HBV)infection(HR=0.231,P=0.014),Child-Pugh class(HR=1.757,P=0.017),maximum tumor diameter(HR=1.908,P=0.003),and subsequent anti-programmed cell death protein-1(PD-1)therapy(HR=0.652,P=0.045)as independent factors influencing OS.CRYO+LEN group had higher incidences of pleural effusion(6.2%vs.0%,P=0.038)and skin frostbite(8.3%vs.0%,P=0.011),while TACE+LEN group was more prone to abdominal pain(7.3%vs.0%,P=0.021)and non-infectious fever(24%vs.5.2%,P=0.001).There were no significant differences in other AEs between the two groups(P>0.05).Conclusions CRYO combined with LEN demonstrates similar clinical benefits and manageable safety profiles to TACE combined with LEN in the treatment of uHCC,providing an effective alternative therapeutic option for patients unsuitable for TACE.

王迪;常秀娟;宫嫚;张伟;张慧鑫;孔慧芳;黄加干;高旭东;曾珍

北京大学302临床医学院,北京 100039解放军总医院肝病医学部,北京 100039解放军总医院肝病医学部,北京 100039解放军总医院肝病医学部,北京 100039解放军总医院肝病医学部,北京 100039解放军总医院肝病医学部,北京 100039解放军总医院肝病医学部,北京 100039解放军总医院肝病医学部,北京 100039北京大学302临床医学院,北京 100039||解放军总医院肝病医学部,北京 100039

医药卫生

不可切除肝细胞癌经肝动脉化疗栓塞冷冻消融仑伐替尼

unresectable hepatocellular carcinomatransarterial chemoembolizationcryoablationlenvatinib

《解放军医学杂志》 2026 (4)

531-541,11

This work was supported by the National Natural Science Foundation of China(82570716),the National Science and Technology Major Project(2025ZD01906003),the National Health Commission Research Project(WKZX2023CX020011),and the Natural Science Foundation of Beijing(7252131) 国家自然科学基金(82570716)国家科技部重大专项(2025ZD01906003)国家卫生健康委研究项目(WKZX2023CX020011)北京市自然科学基金(7252131)

10.11855/j.issn.0577-7402.1981.2026.0314

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