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Background and aims <p>Advanced 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.</p> Methods <p>A 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.</p> Results <p>The 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&#xa0;months vs. 13.7&#xa0;months, <i>P</i> = 0.047) and median PFS (11.1&#xa0;months vs. 5.6&#xa0;months, <i>P</i> = 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 <i>TP53</i> mutations (<i>P</i> = 0.048), <i>KRAS</i> mutations (<i>P</i> = 0.037), <i>IDH1</i> mutations (<i>P</i> = 0.033), or <i>BAP1</i> wild-type status (<i>P</i> = 0.039 and <i>P</i> = 0.022), the P-L-G group exhibited a more favorable prognosis compared to the P-L group.</p> Conclusions <p>Advanced 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.</p>

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Effectiveness and safety of PD-1/PD-L1 inhibitors plus lenvatinib with or without Gemox chemotherapy in advanced intrahepatic cholangiocarcinoma

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月16日

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  • Shuofeng Li,
  • Guanhua Yu,
  • Shanshan Wang,
  • Mingming Wang,
  • Chengpei Zhu,
  • Mingjian Piao,
  • Ziyu Xun,
  • Chengjie Li,
  • Boyu Sun,
  • Jiashuo Chao,
  • Jie Pan,
  • Kang Zhou,
  • Xinyuan Chen,
  • Xiaobo Yang,
  • Haitao Zhao

摘要

Background and aims

Advanced 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.

Methods

A 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.

Results

The 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.

Conclusions

Advanced 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.