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Background <p>This research aimed to assess the efficacy and safety of a regimen combining lenvatinib with an anti-PD-1 antibody or chemotherapy in patients with advanced intrahepatic cholangiocarcinoma (ICC).</p> Methods <p>A two-arm, open-label, phase II trial was carried out. Participants in Arm A received 240&#xa0;mg of toripalimab intravenously on day 1 of each 3-week cycle, plus daily oral lenvatinib at 8&#xa0;mg (&lt; 60&#xa0;kg) or 12&#xa0;mg (≥60 kg).&#xa0;Participants in Arm B were administered the same daily lenvatinib in combination with GEMOX chemotherapy: 85&#xa0;mg/m<sup>2</sup> oxaliplatin on day 1, and 1&#xa0;g/m<sup>2</sup> gemcitabine on days 1 and 8 every 3&#xa0;weeks for 6-8 cycles. The primary endpoint was the objective response rate (ORR) per RECIST 1.1, with secondary endpoints included treatment-related adverse events (AEs), overall survival (OS), and progression-free survival (PFS).</p> Results <p>Sixty one patients were recruited, with 31 in Arm A and 30 in Arm B. The ORR of Arm A was 32.3% (10/31; 95% CI: 16.7%–51.4%), and three patients underwent surgery after tumor downstaging. The median OS was 20.3 months (95% CI: 9.3–27.1), and median PFS was 8.9 months (95% CI: 4.2–13.9). Arm B showed an ORR of 40.0% (12/30; 95% CI: 22.7%–59.4%), and one patient proceeded to surgery after downstaging. Median OS was 15.5 months (95% CI: 9.6–23.8), and median PFS was 8.0 months (95% CI: 5.0–11.4). Adverse events (AEs) related to treatment were observed in most patients, with grade 3–4 AEs in 35.5% of Arm A and 40.0% of Arm B. The most frequent AEs were fatigue (71% vs. 63%), paresthesia (45% vs. 40%), and gingivitis (45% vs. 20%). Grade 4 thrombocytopenia occurred in 6.7% of Arm B. No grade 5 AEs were observed. Peripheral blood analysis showed monocyte levels decreased in PR(partial &#xa0;response) patients in Arm A but increased in PR patients in Arm B.</p> Conclusions <p>The Combination of lenvatinib with either anti-PD-1 antibody or GEMOX chemotherapy is a well-tolerated and effective treatment for advanced ICC.</p> Trail registration <p>ClinicalTrials.gov, NCT04361331</p>

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Anti-PD1 antibody toripalimab combined with lenvatinib, or GEMOX chemotherapy combined with lenvatinib as first-line therapy in patients with advanced intrahepatic cholangiocarcinoma: a randomized, open, two-cohort Phase 2 Study

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  • 发表日期：

    2025年10月21日

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  • Xiao-Yong Huang,
  • Guo-Ming Shi,
  • Zhi-Tao Zheng,
  • Hui-Chuan Sun,
  • Fei Liang,
  • Yuan Ji,
  • Yi Chen,
  • Guo-Huan Yang,
  • Zhi-Qiang Hu,
  • Jia-Cheng Lu,
  • Xian-Long Meng,
  • Xiao-Jun Guo,
  • Chao-Chen Zhang,
  • Jia Fan,
  • Jian Zhou

摘要

Background

This research aimed to assess the efficacy and safety of a regimen combining lenvatinib with an anti-PD-1 antibody or chemotherapy in patients with advanced intrahepatic cholangiocarcinoma (ICC).

Methods

A two-arm, open-label, phase II trial was carried out. Participants in Arm A received 240 mg of toripalimab intravenously on day 1 of each 3-week cycle, plus daily oral lenvatinib at 8 mg (< 60 kg) or 12 mg (≥60 kg). Participants in Arm B were administered the same daily lenvatinib in combination with GEMOX chemotherapy: 85 mg/m2 oxaliplatin on day 1, and 1 g/m2 gemcitabine on days 1 and 8 every 3 weeks for 6-8 cycles. The primary endpoint was the objective response rate (ORR) per RECIST 1.1, with secondary endpoints included treatment-related adverse events (AEs), overall survival (OS), and progression-free survival (PFS).

Results

Sixty one patients were recruited, with 31 in Arm A and 30 in Arm B. The ORR of Arm A was 32.3% (10/31; 95% CI: 16.7%–51.4%), and three patients underwent surgery after tumor downstaging. The median OS was 20.3 months (95% CI: 9.3–27.1), and median PFS was 8.9 months (95% CI: 4.2–13.9). Arm B showed an ORR of 40.0% (12/30; 95% CI: 22.7%–59.4%), and one patient proceeded to surgery after downstaging. Median OS was 15.5 months (95% CI: 9.6–23.8), and median PFS was 8.0 months (95% CI: 5.0–11.4). Adverse events (AEs) related to treatment were observed in most patients, with grade 3–4 AEs in 35.5% of Arm A and 40.0% of Arm B. The most frequent AEs were fatigue (71% vs. 63%), paresthesia (45% vs. 40%), and gingivitis (45% vs. 20%). Grade 4 thrombocytopenia occurred in 6.7% of Arm B. No grade 5 AEs were observed. Peripheral blood analysis showed monocyte levels decreased in PR(partial  response) patients in Arm A but increased in PR patients in Arm B.

Conclusions

The Combination of lenvatinib with either anti-PD-1 antibody or GEMOX chemotherapy is a well-tolerated and effective treatment for advanced ICC.

Trail registration

ClinicalTrials.gov, NCT04361331