信迪利单抗联合吉西他滨及顺铂治疗晚期肝内胆管细胞癌的临床疗效

摘要/Abstract

摘要： 目的观察信迪利单抗联合吉西他滨及顺铂治疗晚期肝内胆管细胞癌(ICC)患者的疗效和安全性。方法纳入2022年12月至2024年12月无锡市太湖医院诊治的晚期ICC患者84例,根据治疗方式不同分为联合组和参照组,每组42例,分别接受信迪利单抗联合吉西他滨及顺铂或单纯吉西他滨及顺铂方案治疗3个周期。比较两组患者的临床疗效、肝功能指标,采用Kaplan-Meier法分析1年总体生存率,并比较不良反应发生情况。结果联合组疗效显著高于参照组。联合组患者的客观缓解率为59.5%(25/42),疾病控制率为90.5%(38/42),均显著高于参照组的31.0%(13/42)和69.0%(29/42)(P<0.05)。在肝功能指标方面,治疗后联合组血清ALT、AST和TBil水平分别为(41.3±12.6)U/L、(45.7±14.8)U/L和(21.4±7.6)μmol/L,均显著低于参照组的(58.6±15.4)U/L、(63.2±17.6)U/L和(29.8±9.4)μmol/L(P<0.05),血清Alb水平为(38.9±4.3)g/L,高于参照组的(35.1±4.0)g/L(P<0.05)。Kaplan-Meier法分析显示,随访12个月内联合组与参照组的1年总体生存率分别为71.4%(30/42)和47.6%(20/42)(χ²=8.788,P=0.003)。两组不良反应发生率差异无统计学意义(P>0.05)。结论应用信迪利单抗联合吉西他滨及顺铂治疗ICC患者具有确切的临床疗效,具有临床应用价值。

关键词: 肝内胆管癌, 信迪利单抗, 吉西他滨及顺铂, 程序性死亡受体-1, 治疗

Abstract: Objective To assess the clinical outcomes and safety profile of sintilimab in combination with gemcitabine and cisplatin for patients diagnosed with advanced intrahepatic cholangiocarcinoma (ICC). Methods A total of 84 advanced ICC patients treated at Wuxi Taihu Hospital between December 2022 and December 2024 were enrolled and categorized into two groups based on therapeutic regimen. The experimental group (n=42) received sintilimab alongside gemcitabine and cisplatin, while the control group (n=42) was administered gemcitabine and cisplatin alone, with both groups completing three treatment cycles. Efficacy evaluation, liver function markers, and adverse event occurrence were compared between the groups. Overall survival (OS) over 12 months was evaluated using Kaplan-Meier methodology. Results The experimental group demonstrated superior therapeutic response compared to the control group. Objective response rate (ORR) was 59.5% (25/42) in the experimental group versus 31.0% (13/42) in the control group, and disease control rate (DCR) reached 90.5% (38/42) compared to 69.0% (29/42), with both differences being statistically significant (P<0.05). Post-treatment measurements indicated lower serum alanine aminotransferase (ALT, 41.3 ± 12.6 U/L vs. 58.6 ± 15.4 U/L), aspartate aminotransferase (AST, 45.7 ± 14.8 U/L vs. 63.2 ± 17.6 U/L), and total bilirubin (21.4 ± 7.6 μmol/L vs. 29.8 ± 9.4 μmol/L) levels in the experimental group (all P<0.05). Conversely, serum albumin was higher in the experimental group (38.9 ± 4.3 g/L vs. 35.1 ± 4.0 g/L, P<0.05). Survival analysis showed a 12-month OS rate of 71.4% (30/42) for the experimental group, significantly exceeding the 47.6% (20/42) observed in the control group (log-rank χ²=8.788, P=0.003). The frequency of adverse events did not differ meaningfully between the two groups (P>0.05). Conclusion The therapeutic regimen combining sintilimab with gemcitabine and cisplatin exhibits significant clinical benefits and favorable safety in advanced ICC management, supporting its promising role in clinical practice.

Key words: Intrahepatic cholangiocarcinoma, Sintilimab, Gemcitabine and cisplatin, Programmed death receptor-1, Therapy

姚慰峰, 周仁贵. 信迪利单抗联合吉西他滨及顺铂治疗晚期肝内胆管细胞癌的临床疗效[J]. 肝脏, 2026, 31(8): 1120-1123.

Yao Weifeng, Zhou Rengui. Efficacy of sintilimab combined with gemcitabine and cisplatin in the treatment of patients with advanced intrahepatic cholangiocarcinoma[J]. Chinese Hepatolgy, 2026, 31(8): 1120-1123.

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