Chemotherapy combined with immunotherapy vs. chemotherapy: comparison of safety and efficacy in adjuvant therapy for intrahepatic cholangiocarcinoma

Background: The aim of this retrospective study was to investigate the efficacy and safety of different regimes among patients with intrahepatic cholangiocarcinoma (ICC). Methods: The data of 232 patients (2011-2023) at the Tianjin Medical University Cancer Institute&Hospital were analyzed. Patients were divided into 5 different groups: non-AT group (underwent surgical treatment alone), gemcitabine plus oxaliplatin (GEMOX), gemcitabine plus immunotherapy, capecitabine monotherapy and capecitabine plus immunotherapy. Results: Significant differences were observed in both RFS (p = 0.045) and OS (p = 0.0084) between CH group (GEMOX and capecitabine) and non-AT group. No significant difference was observed in RFS (p = 0.73) or OS (p = 0.47) between capecitabine and GEMOX. However, GEMOX group had higher incidence of grade 3-4 adverse reactions(n=7, 17.1%). When comparing the CH and gemcitabine plus immunotherapy and capecitabine plus immunotherapy group, no significant differences were observed in RFS or OS. In subgroup analysis, patients with CA19-9>39 U/ml and ALP>100 U/L may benefited from chemotherapy combined with immunotherapy. Conclusion: Compared to GEMOX, capecitabine showed no significant difference in prognosis but exhibited a more favorable safety profile. Although the addition of immunotherapy did not confer further benefit in the overall cohort, it was associated with improved efficacy in patients with CA19-9 >39 U/ml or ALP >100 U/L. These findings require confirmation in larger studies.