ArticleBMC cancer2026
Effectiveness and safety of PD-1/PD-L1 inhibitors plus lenvatinib with or without Gemox chemotherapy in advanced intrahepatic cholangiocarcinoma.
Article in BMC cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
BACKGROUND AND
aimsAdvanced intrahepatic cholangiocarcinoma (ICC) is characterized by a poor prognosis. This study evaluated the efficacy and safety of programmed cell death protein 1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitors combined with lenvatinib, with or without gemcitabine and oxaliplatin (Gemox) chemotherapy.
methodsA retrospective cohort analysis was performed on patients with advanced ICC who received treatment with PD-1/PD-L1 inhibitors and lenvatinib, with or without Gemox chemotherapy, between February 2017 and February 2024. Outcomes included progression-free survival (PFS), overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety.
resultsThe study included 107 patients, comprising 67 patients treated with PD-1/PD-L1 inhibitors and lenvatinib (P-L group) and 40 patients treated with PD-1/PD-L1 inhibitors, lenvatinib, and Gemox chemotherapy (P-L-G group). In comparison to the P-L group, the P-L-G group had longer median OS (16.4 months vs. 13.7 months, P = 0.047) and median PFS (11.1 months vs. 5.6 months, P = 0.004). Furthermore, the P-L-G group had a higher ORR (60.00% vs. 22.39%) and DCR (85.00% vs. 73.13%). All patients experienced adverse events (AEs), with 33 patients (49.25%) in the P-L group and 22 patients (55.00%) in the P-L-G group reporting grade 3-4 AEs. No grade 5 AEs were observed, and all AEs were manageable. Meanwhile, among patients with TP53 mutations (P = 0.048), KRAS mutations (P = 0.037), IDH1 mutations (P = 0.033), or BAP1 wild-type status (P = 0.039 and P = 0.022), the P-L-G group exhibited a more favorable prognosis compared to the P-L group.
conclusionsAdvanced ICC patients may derive greater benefit from the triple combination therapy of PD-1/PD-L1 inhibitors, lenvatinib, and Gemox chemotherapy without an increase in AEs. This regimen holds potential as an effective first-line treatment for advanced ICC.
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