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<p>In this phase 2 study (NCT05047991), patients with unresectable metastatic pancreatic adenocarcinoma were randomized to receive NALIRIFOX (liposomal irinotecan, 5-FU, leucovorin, and oxaliplatin) or gemcitabine plus nab-paclitaxel. The primary endpoint was progression free survival (PFS). Secondary endpoints included other efficacy outcomes (overall survival, objective response rate, disease control rate, and duration of response), as well as safety, pharmacokinetic parameters, and evaluation of the relationship between <i>UGT1A1*6</i> and <i>UGT1A1*28</i> polymorphisms and safety. A total of 117 patients were enrolled and randomly assigned to NALIRIFOX (<i>n</i> = 78) or gemcitabine plus nab-paclitaxel (<i>n</i> = 39). At a median follow-up of 18.7 months (interquartile range [IQR], 7.5–22.1) for NALIRIFOX and 12.1 months (IQR: 6.4–14.8) for the gemcitabine plus nab-paclitaxel, median PFS was 7.6 months (95% CI 5.52–9.23) with NALIRIFOX versus 3.7 months (95% CI 3.38-5.32) with gemcitabine plus nab-paclitaxel (hazard ratio, 0.56; 95% CI, 0.35–0.88; P = 0.0115). ≥ Grade 3 treatment-emergent adverse events (TEAEs) occurred in 73.1% of patients receiving NALIRIFOX and 84.6% of patients receiving gemcitabine plus nab-paclitaxel, respectively. Despite the premature termination (predetermined sample size of <i>n</i> = 153 not reached) of the study, NALIRIFOX demonstrated improvement in PFS compared with gemcitabine plus nab-paclitaxel, with a manageable safety profile in Chinese patients with advanced pancreatic adenocarcinoma.</p>

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NALIRIFOX versus gemcitabine plus nab-paclitaxel in Chinese patients with advanced pancreatic adenocarcinoma: a randomized, open-label phase II trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年1月16日

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  • Chuntao Gao,
  • Yanqiao Zhang,
  • Xiujuan Qu,
  • Xingyun Chen,
  • Jingdong Zhang,
  • Heshui Wu,
  • Meili Sun,
  • Yong Zha,
  • Junbin Wang,
  • Yusheng Wang,
  • Zhihua Li,
  • Jinghua Gao,
  • Rongbo Lin,
  • Aimin Zang,
  • Huiqing Zhang,
  • Xianglin Yuan,
  • Chengyou Du,
  • Jun Zhao,
  • Yongsheng Yang,
  • Xuetao Shi,
  • Wei Cheng,
  • Bangmao Wang,
  • Shikai Wu,
  • Tiansuo Zhao,
  • Jian Wang,
  • Song Gao,
  • Xiuchao Wang,
  • Weidong Ma,
  • Rui Liu,
  • Yehui Shi,
  • Yanping Liu,
  • Yijiao Xie,
  • Miao Niu,
  • Fuchen Zhao,
  • Jun Yu,
  • Jihui Hao

摘要

In this phase 2 study (NCT05047991), patients with unresectable metastatic pancreatic adenocarcinoma were randomized to receive NALIRIFOX (liposomal irinotecan, 5-FU, leucovorin, and oxaliplatin) or gemcitabine plus nab-paclitaxel. The primary endpoint was progression free survival (PFS). Secondary endpoints included other efficacy outcomes (overall survival, objective response rate, disease control rate, and duration of response), as well as safety, pharmacokinetic parameters, and evaluation of the relationship between UGT1A1*6 and UGT1A1*28 polymorphisms and safety. A total of 117 patients were enrolled and randomly assigned to NALIRIFOX (n = 78) or gemcitabine plus nab-paclitaxel (n = 39). At a median follow-up of 18.7 months (interquartile range [IQR], 7.5–22.1) for NALIRIFOX and 12.1 months (IQR: 6.4–14.8) for the gemcitabine plus nab-paclitaxel, median PFS was 7.6 months (95% CI 5.52–9.23) with NALIRIFOX versus 3.7 months (95% CI 3.38-5.32) with gemcitabine plus nab-paclitaxel (hazard ratio, 0.56; 95% CI, 0.35–0.88; P = 0.0115). ≥ Grade 3 treatment-emergent adverse events (TEAEs) occurred in 73.1% of patients receiving NALIRIFOX and 84.6% of patients receiving gemcitabine plus nab-paclitaxel, respectively. Despite the premature termination (predetermined sample size of n = 153 not reached) of the study, NALIRIFOX demonstrated improvement in PFS compared with gemcitabine plus nab-paclitaxel, with a manageable safety profile in Chinese patients with advanced pancreatic adenocarcinoma.