信迪利单抗联合载药微球经动脉化疗栓塞术治疗中晚期原发性肝癌的临床研究

肝脏 ›› 2025, Vol. 30 ›› Issue (10): 1340-1343.

信迪利单抗联合载药微球经动脉化疗栓塞术治疗中晚期原发性肝癌的临床研究

王书山, 刘超, 叶静, 陈芬, 李洪腾

271000 泰安泰安市肿瘤医院介入科(王书山,刘超,陈芬,李洪腾),放疗科(叶静)

收稿日期:2025-02-08 出版日期:2025-10-31 发布日期:2025-12-16
通讯作者: 李洪腾,Email:15662053000@163.com
基金资助:
泰安市科技创新发展项目(2020NS226)

A clinical investigation of sintilimab in combination with transarterial microsphere chemoembolization for the treatment of advanced primary liver cancer

WANG Shu-shan¹, LIU Chao¹, YE Jing², CHEN Fen¹, LI Hong-teng¹

1. Department of Interventional,Tai′an Tumor Hospital, Tai′an 271000,China;
2. Department of Radiotherapy, Tai′an Tumor Hospital, Tai′an 271000,China

Received:2025-02-08 Online:2025-10-31 Published:2025-12-16
Contact: LI Hong-teng,Email:15662053000@163.com

摘要/Abstract

摘要： 目的分析中晚期原发性肝癌(PLC)应用信迪利单抗联合载药微球经动脉化疗栓塞术(DEB-TACE)治疗的效果。方法纳入2021年3月至2024年4月山东省泰安市肿瘤医院收治的97例中晚期PLC患者,按治疗方法分为对照组(n=47,接受DEB-TACE治疗)与观察组(n=50,另加用信迪利单抗),并比较2组疗效。结果治疗效果方面,观察组ORR为58.00%(29/50),好于对照组的36.17%(17/47);观察组DCR为66.00%(33/50),好于对照组的44.68%(21/47),差异均有统计学意义(P<0.05)。肝功能指标方面,治疗后,观察组TBil、AST、ALT分别为[(12.30±1.24)μmol/L、(31.02±2.45)U/L、(24.63±3.52)U/L],对照组为[(14.02±1.29)μmol/L、(37.18±2.69)U/L、(29.85±3.74)U/L],两组比较差异均有统计学意义(P<0.05)。治疗后,免疫指标方面,观察组CEA、AFP-L3、AFP分别为[(113.63±21.52)μg/L、(185.63±15.74)ng/mL、(86.96±12.04)ng/mL],对照组则为[(146.96±23.85)μg/L、(267.54±18.96)ng/mL、(136.52±14.17)ng/mL],均P<0.05。免疫功能方面,治疗后,观察组CD3⁺、CD4⁺、CD8⁺分别为[(65.63±3.41)%、(43.36±4.43)%、(25.63±2.74)%],对照组则为[(61.63±3.02)%、(40.39±4.87)%、(27.63±2.98)%],两组比较差异有统计学意义(P<0.05)。不良反应发生率方面,观察组为6.00％(6/50),对照组6.38%(6/47),两组比较差异无统计学意义(P>0.05)。随访6个月,观察组病死率为4.00%,较对照组的10.64%低(Log-rank χ²=0.353,P=0.553)。结论采取信迪利单抗联合DEB-TACE治疗效果确切,可改善肿瘤标志物、肝功能水平,提升免疫功能,不增加不良反应,病死率较低。

关键词: 信迪利单抗, 经动脉载药微球化疗栓塞, 中晚期原发性肝癌

Abstract: Objective To assess the effectiveness of sintilimab in combination with drug-loaded microspheres transarterial chemoembolization (DEB-TACE) for the treatment of advanced primary liver cancer (PLC). Methods A total of 97 patients with advanced PLC treated at Tai′an Tumor Hospital in Shandong Province from March 2021 to April 2024 were included in the study. They were divided into two groups based on their treatment methods. The control group consisted of 47 patients who underwent DEB-TACE treatment, the observation group had fifty patients and they were treated with sintilimab. The treatment effects, alterations in liver function index, levels of tumor markers and immune function,as well as the incidence of adverse reactions were compared between the two groups. Results The treatment effects of the observation group were better than those of the control group [objective response rate: 58.00% (29/50) vs. 36.17% (17/47);disease control rate:66.00% (33/50) vs. 44.68% (21/47)], with improved liver function index [total bilirubin(TBil): (12.30±1.24) μmol/L vs. (14.02±1.29) μmol/L;aspartate aminotransferase (AST): (31.02±2.45) U/L vs. (37.18±2.69) U/L; alanine aminotransferase (ALT):(24.63±3.52) U/L vs. (29.85±3.74) U/L], immue indexes of tumor markers [carcinoembryonic antigen (CEA): (65.63±3.41)% vs. (61.63±3.02)%; alpha-fetoproteinvariant-L3 (AFP-L3): (43.36±4.43)% vs. (40.39±4.87)%; alpha-fetoprotein (AFP): (25.63±2.74)% vs. (27.63±2.98)%] and indexes of immune function [CD3⁺: (65.63±3.41)% vs. (61.63±3.02)%;CD4⁺: (43.36±4.43)% vs. (40.39±4.87)%; CD8⁺: (25.63±2.74)% vs.(27.63±2.98)%] (All P<0.05). The incidence of adverse reactions of the observation group was lower than that of the control group [6.38% (6/47) vs. 6.00% (6/50)] (P>0.05). After a 6-month follow-up, the mortality rates between the two groups were compared (Log-rank χ²=0.353, P=0.553). Conclusion The combination of sintilimab and DEB-TACE demonstrates significant therapeutic effects in improving the levels of tumor markers, indexes of liver function and immune function, without increasing adverse reactions, and is associated with a lower mortality rate.

Key words: Sintilimab, Transarterial microsphere chemoembolization, Intermediate and advanced primary liver cancer

王书山, 刘超, 叶静, 陈芬, 李洪腾. 信迪利单抗联合载药微球经动脉化疗栓塞术治疗中晚期原发性肝癌的临床研究[J]. 肝脏, 2025, 30(10): 1340-1343.

WANG Shu-shan, LIU Chao, YE Jing, CHEN Fen, LI Hong-teng. A clinical investigation of sintilimab in combination with transarterial microsphere chemoembolization for the treatment of advanced primary liver cancer[J]. Chinese Hepatolgy, 2025, 30(10): 1340-1343.

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参考文献

[1] Zheng R, Zhang S, Zeng H, et al. Cancer incidence and mortality in China, 2016[J]. J Natl Cancer Cent. 2022,2(1):1-9.
[2] 杜尚云,翁莉,武敏. 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[J]. 实用肝脏病杂志,2023,26(1):116-119.
[3] 刘钊,李智,杨凯仑,等. 原发性肝癌经肝动脉化疗栓塞术后短期病死率及死因分析[J]. 临床肝胆病杂志,2022,38(11):2510-2513.
[4] 梁黎,丁文彬,徐管梅,等. 载药微球经动脉化疗栓塞对比碘油栓塞治疗中晚期肝癌的有效性及安全性分析[J]. 河北医学,2023,29(12):2049-2054.
[5] 刘帅,张凯,张晓青,等. 依托泊苷+洛铂+安罗替尼+信迪利单抗一线治疗ES-SCLC的疗效评价及生存分析[J]. 重庆医学,2024,53(15):2291-2295.
[6] 叶小荣,程涛,易弼顺. 信迪利单抗联合XELIRI方案治疗结直肠癌的疗效及预后影响因素[J]. 中国药物与临床,2024,24(16):1068-1072.
[7] 中华人民共和国国家卫生健康委员会医政司. 原发性肝癌诊疗指南(2024年版)[J]. 中华肝脏病杂志,2024,32(7):581-630.
[8] 蒋琼慧,路泽军,杨平. 肿瘤免疫治疗疗效评价标准——iRECIST解读[J]. 转化医学杂志,2020,9(1):57-60.
[9] Gu S, Menzer C, Hay J L, et al. PRO-CTCAE reveals under-recognition of dermatologic symptom burden in hospitalized cancer patients[J]. Support Care Cancer,2023,31(6):337.
[10] 杨虓,黄文,钟辉,等. Callispheres可载药微球经导管动脉化疗栓塞治疗膀胱癌的疗效及对血清肿瘤标志物和VEGF,bFGF水平的影响[J]. 临床和实验医学杂志,2024,23(11):1175-1180.
[11] 于广计,张永会,徐慧超,等. DEB-TACE联合瑞戈非尼二线治疗不可切除晚期肝细胞癌的疗效和安全性[J]. 广西医学,2023,45(12):1402-1407.
[12] 陈秋平,邵明义,张容容,等. 信迪利单抗联合化疗方案一线治疗晚期,复发或转移性食管鳞状细胞癌的成本-效用分析[J]. 中国药房,2023,34(3):345-349.
[13] 徐仁良,沈松柏,余龙伍,等. 载药微球经动脉化疗栓塞与传统肝动脉化疗栓塞分别联合索拉非尼治疗中晚期肝细胞肝癌的有效性和安全性对比[J]. 临床外科杂志,2023,31(4):383-386.
[14] 陈园园,安慧娟,王晓聪. 信迪利单抗联合FOLFOX方案治疗晚期不可切除原发性肝癌疗效及安全性分析[J]. 实用癌症杂志,2024,39(9):1560-1563.
[15] 卢芳,施尧,张晨曦,等. 信迪利单抗治疗晚期肝癌的有效性及安全性分析[J]. 医学研究与战创伤救治,2023,36(8):852-855.