Ulinastatin in the treatment of radiotherapy-induced oral mucositis in locoregionally advanced nasopharyngeal carcinoma: a phase 3 randomized clinical trial

Xuguang Wang, Haijun Wu, Feng Lei, Zhigang Liu, Guanzhu Shen, Xuefeng Hu, Yijing Ye, Manyi Zhu, Huageng Huang, Boyu Chen, Runda Huang, Chong Zhao (), Jingjing Miao () and Lin Wang ()
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Xuguang Wang: Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy
Haijun Wu: First People’s Hospital of Foshan
Feng Lei: The People’s Hospital of Zhongshan City
Zhigang Liu: Southern Medical University
Guanzhu Shen: The Third Affiliated Hospital of Sun Yat-sen University
Xuefeng Hu: First People’s Hospital of FoShan Affiliated with Sun Yat-Sen University
Yijing Ye: Zhongshan City People’s Hospital
Manyi Zhu: Chinese Academy of Medical Sciences and Peking Union Medical College
Huageng Huang: Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy
Boyu Chen: Sun Yat-sen University Cancer Center
Runda Huang: Sun Yat-sen University Cancer Center
Chong Zhao: Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy
Jingjing Miao: Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy
Lin Wang: Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy

Nature Communications, 2025, vol. 16, issue 1, 1-9

Abstract: Abstract Radiotherapy-induced oral mucositis (RTOM) is a common side effect of radiotherapy in locoregionally advanced nasopharyngeal carcinoma (LA-NPC) receiving concurrent chemoradiotherapy (CCRT). In this phase 3 trial, we aim to evaluate the efficacy and safety of Ulinastatin (UTI) for the prevention and treatment of RTOM in LA-NPC patients (NCT03387774). The primary endpoint is the incidence of grade ≥3 acute RTOM during radiotherapy. Secondary endpoints include cumulative incidence of RTOM, recovery rate, the onset time and duration of grade ≥3 RTOM, oral pain (severe), safety and survival outcomes. 179 eligible patients are randomly assigned to UTI Group (n = 89) or Control group (n = 90). All UTI group patients complete UTI treatment as planned, and both groups complete scheduled CCRT. The incidence of grade 3 RTOM is significantly lower in UTI group compared with control group (25.8% vs 41.1%, P = 0.030). The trial meet its prespecified primary endpoint. No Ulinastatin related adverse events are observed during treatment. The 3-year overall survival (OS), locoregional relapse-free survival (LRRFS), distant metastasis-free survival (DMFS) and progression-free survival (PFS) in UTI group and control group are similar between two groups. In this work, Ulinastatin can effectively reduce the severity of RTOM and oral pain without increasing toxicity and compromising survivals.

Date: 2025
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DOI: 10.1038/s41467-025-57884-6

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