NALIRIFOX versus gemcitabine plus nab-paclitaxel in Chinese patients with advanced pancreatic adenocarcinoma: a randomized, open-label phase II trial
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.
Authors
- Meili Sun (ORCID: https://orcid.org/0000-0002-4914-6508)
- Jingwei Yu (ORCID: https://orcid.org/0000-0002-6299-9708)
- Tiansuo Zhao (ORCID: https://orcid.org/0000-0003-1631-6299)
- J. Wang
- Yong Zha
- Jihui Hao (ORCID: https://orcid.org/0000-0002-1607-1730)
- Xiaohan Qu (ORCID: https://orcid.org/0000-0003-1494-2333)
- Yanping Liu (ORCID: https://orcid.org/0000-0002-8338-5991)
- Junbin Wang (ORCID: https://orcid.org/0000-0001-8877-0509)
- Xuetao Shi (ORCID: https://orcid.org/0000-0003-4313-6664)
- Chengyou Du
- Xingyun Chen
- Bangmao Wang
- Yijiao Xie
- Y. Shi
- H. Wu
- Aimin Zang
- Weidong Ma
- Shikai Wu
- Fuchen Zhao
- Rui Liu
- Miao Niu
- Song Gao
- Huiqing Zhang
- Yongsheng Yang
- Zhihua Li
- Jihui Hao
- Rongbo Lin
- Xianglin Yuan
- Wei Cheng
- Jun Zhao
- Jingdong Zhang
Institutions
- Union Hospital (HK)
- Harbin Medical University (CN)
- Sun Yat-sen University (CN)
- Shanxi Medical University (CN)
- Changzhi Medical College (CN)
- Peking University (CN)
- Tianjin Medical University General Hospital (CN)
- Tianjin Medical University Cancer Institute and Hospital (CN)
- Second People's Hospital of Yunnan Province (CN)
- Jiangxi Provincial Cancer Hospital (CN)
- Sun Yat-sen Memorial Hospital (CN)
- Cangzhou Central Hospital (CN)
- Third Affiliated Hospital of Harbin Medical University (CN)
- Jinan Central Hospital (CN)
- First Hospital of Shanxi Medical University (CN)
- The Affiliated Yongchuan Hospital of Chongqing Medical University (CN)
- Peking University First Hospital (CN)
- First Hospital of China Medical University (CN)
- Affiliated Hospital of Hebei University (CN)
- Second Affiliated Hospital of Jilin University (CN)
- Shijiazhuang Yiling Pharmaceutical (China) (CN)
- Hunan Provincial People's Hospital (CN)
- Fujian Provincial Cancer Hospital (CN)
- First Affiliated Hospital of Bengbu Medical College (CN)
- Tongji Hospital (CN)
- Liaoning Cancer Hospital & Institute (CN)
- Shandong First Medical University (CN)
- Huazhong University of Science and Technology (CN)
- Tianjin Medical University (CN)
- Chongqing Medical University (CN)
- China Medical University (CN)
Publication Details
- Journal
- Nature Communications
- Published
- 2026-01-16
- DOI
- https://doi.org/10.1038/s41467-026-68409-0
- Primary Topic
- Pancreatic and Hepatic Oncology Research
- Type
- article
- Field-Weighted Citation Impact
- 0.00