信迪利单抗联合TACE治疗肝癌术后继发不可切除肝内转移的临床疗效及预后分析

摘要/Abstract

摘要： 目的评估信迪利单抗联合经导管动脉化疗栓塞(TACE)治疗术后继发不可切除肝内转移的HCC患者的临床疗效及预后。方法前瞻性研究,纳入 2017年1月至2022年12月于我院接受手术切除后出现不可切除肝内转移的80例肝细胞癌患者,按随机数字表法分为联合组(信迪利单抗联合TACE,40例)和单一组(TACE,40例)。比较两组的临床疗效、血清肿瘤标志物、免疫指标及不良反应发生率,并进行生存分析。结果治疗后,联合组客观缓解率[52.50% vs. 25.00%]和疾病控制率[92.50% vs. 72.50% ]均显著高于单一组(P<0.05)。联合组肿瘤抗原125(CA125)[(28.47±3.23)U/mL vs.(39.16±4.79)U/mL]、甲胎蛋白(AFP)[(403.85±32.79)ng/mL vs.(513.85±47.93)ng/mL]、CD3⁺[(70.14±7.03)% vs.(64.85±5.14)%]、 CD4⁺/CD8⁺[(1.78±0.51) vs. (1.47±0.54)]均显著优于单一组(P<0.05)。两组出现肝功能异常(22.50% vs. 25.00%)、疲劳(50.00% vs. 52.50%)、发热(7.50% vs. 8.00%)、白细胞计数减少(32.50% vs. 35.00%)不良反应的发生率比较,差异无统计学意义(P>0.05)。Kaplan-Meier生存曲线显示,联合组平均总生存期(OS)(21.6个月vs. 19.1个月)及中位无进展生存期(PFS)(17.4个月 vs. 11.8个月)均长于单一组(P<0.05)。结论联合信迪利单抗与TACE治疗肝细胞癌患者,可显著提升疗效并增强患者免疫功能,还可延长OS和PFS,同时未增加严重不良反应,显示出良好的临床应用价值。

关键词: 肝细胞癌, 信迪利单抗, 经导管动脉化疗栓塞, 临床疗效, 预后分析

Abstract: Objective This study aimed to evaluate the clinical efficacy and prognosis of sintilimab combined with transarterial chemoembolization (TACE) treatments on patients with unresectable intrahepatic metastases of hepatocellular carcinoma (HCC) after surgery. Methods A prospective study was conducted on 80 patients collected from January 2017 to December 2022 with unresectable intrahepatic metastatic HCC following surgical resection. All patients were randomly assigned to either the combination group (sintilimab plus TACE, n=40) or the monotherapy group (TACE alone, n=40). The clinical efficacy, serum tumor markers, immune indices, and adverse event incidence were compared between the two groups. A survival analysis was also performed. Results After treatment, the objective response rate (ORR) (52.50% vs. 25.00%) and disease control rate (DCR) (92.50% vs. 72.50%) were significantly higher in the combination group than those in the monotherapy group (P<0.05). The combination group exhibited significantly lower levels of cancer antigen 125 (CA125) [(28.47±3.23) U/mL vs. (39.16±4.79) U/mL] and alpha-fetoprotein (AFP) [(403.85±32.79) ng/mL vs. (513.85±47.93) ng/mL], as well as higher levels of CD3⁺ [(70.14±7.03)% vs. (64.85±5.14)%] and CD4⁺/CD8⁺ ratio [(1.78±0.51) vs. (1.47±0.54)] compared to the monotherapy group (P<0.05). The incidence rates of adverse events, including liver dysfunction (22.5% vs. 25.00%), fatigue (50.00% vs. 52.50%), fever (7.50% vs. 8.00%), and leukopenia (32.50% vs. 35.00%), showed no significant differences between the two groups (P>0.05). Kaplan-Meier survival analysis revealed that the combination group had a longer median overall survival (OS) (21.6 months vs. 19.1 months) and median progression-free survival (PFS) (17.4 months vs. 11.8 months) compared to the monotherapy group (P<0.05). Conclusion The combination of sintilimab and TACE significantly improves therapeutic efficacy, enhances immune function, and prolongs OS and PFS in patients with HCC without increasing severe adverse events, demonstrating favorable clinical application potential.

Key words: Hepatocellular carcinoma, Sintilimab, Transarterial chemoembolization, Clinical efficacy, Prognostic analysis

胡金婷, 孙欣欣, 左传为. 信迪利单抗联合TACE治疗肝癌术后继发不可切除肝内转移的临床疗效及预后分析[J]. 肝脏, 2025, 30(10): 1344-1348.

HU Jin-ting, SUN Xin-xin, ZUO Chuan-wei. An analysis on the clinical efficacy and prognosis of sintilimab combined with TACE in the treatment of postoperative unresectable intrahepatic metastases of hepatocellular carcinoma[J]. Chinese Hepatolgy, 2025, 30(10): 1344-1348.

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