Efficacy of sintilimab combined with gemcitabine and cisplatin in the treatment of patients with advanced intrahepatic cholangiocarcinoma

Abstract

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

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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