Neoadjuvant with low-dose radiotherapy, tislelizumab, albumin-bound paclitaxel, and cisplatin for resectable locally advanced head and neck squamous cell carcinoma: phase II single-arm trial

Zhigang Liu (), Dong Wang, Guanjun Li, Muhua Yi, Zhaoyuan Zhang, Guihua Zhong, Liangfu Xu, Rong Jiang, Yannan Zheng, Linxuan Huang, Yingpeng Peng, Lizhong Liang, Jianpeng Li, Ye Liu, Jun Lai, Xianjuan Lv, Yongqiang Xu, Qiaodan Liu, Zhiqiang Wang, Zhutian Liu, Qinan Yang, Li Nie, Jiao Lei, Xiaotao Huang, Zhijie Liu and Wen Jiang
Additional contact information
Zhigang Liu: Southern Medical University (Dongguan People’s Hospital)
Dong Wang: Southern Medical University (Dongguan People’s Hospital)
Guanjun Li: Southern Medical University (Dongguan People’s Hospital)
Muhua Yi: Southern Medical University (Dongguan People’s Hospital)
Zhaoyuan Zhang: Southern Medical University (Dongguan People’s Hospital)
Guihua Zhong: Southern Medical University (Dongguan People’s Hospital)
Liangfu Xu: Southern Medical University (Dongguan People’s Hospital)
Rong Jiang: Southern Medical University (Dongguan People’s Hospital)
Yannan Zheng: Southern Medical University (Dongguan People’s Hospital)
Linxuan Huang: Southern Medical University (Dongguan People’s Hospital)
Yingpeng Peng: The Fifth Affiliated Hospital of Sun Yat-sen University
Lizhong Liang: The Fifth Affiliated Hospital of Sun Yat-Sen University
Jianpeng Li: Southern Medical University (Dongguan People’s Hospital)
Ye Liu: The Fifth Affiliated Hospital of Sun Yat-sen University
Jun Lai: The Fifth Affiliated Hospital of Sun Yat-sen University
Xianjuan Lv: Southern Medical University (Dongguan People’s Hospital)
Yongqiang Xu: Southern Medical University (Dongguan People’s Hospital)
Qiaodan Liu: The Fifth Affiliated Hospital of Sun Yat-sen University
Zhiqiang Wang: Southern Medical University (Dongguan People’s Hospital)
Zhutian Liu: Southern Medical University (Dongguan People’s Hospital)
Qinan Yang: Southern Medical University (Dongguan People’s Hospital)
Li Nie: Southern Medical University (Dongguan People’s Hospital)
Jiao Lei: Southern Medical University (Dongguan People’s Hospital)
Xiaotao Huang: Southern Medical University (Dongguan People’s Hospital)
Zhijie Liu: Southern Medical University (Dongguan People’s Hospital)
Wen Jiang: The University of Texas MD Anderson Cancer Center

Nature Communications, 2025, vol. 16, issue 1, 1-14

Abstract: Abstract Although pathological complete response (pCR) and major pathological response (MPR) rates of neoadjuvant immunotherapy combined with chemotherapy in head and neck squamous cell carcinoma (HNSCC) trials remain suboptimal, emerging evidence highlights the synergistic potential of combining low-dose radiotherapy with immunotherapy to promote the efficacy of immunotherapy. This phase II, open-label, single-arm, multicenter trial (NCT05343325) enrolled 28 patients with untreated stage III-IVB HNSCC (NeoRTPC02). Patients received neoadjuvant low-dose radiotherapy, the programmed death-1 (PD-1) inhibitor tislelizumab, albumin-bound paclitaxel, and cisplatin for two cycles, followed by radical resection ~4 weeks after treatment completion. The primary endpoint, pCR rate, was achieved in 14 of 23 patients (60.9%; 23/28, 82.1% of the total cohort underwent surgery). Secondary endpoints included MPR rate (21.7%, 5/23), R0 resection rate (100%), and objective response rate (64.3%; 18/28). Treatment-related adverse events were manageable, with grade 3 or 4 treatment-related adverse events occurring in 10 (35.7%) patients. No surgical delays were observed. Single-cell RNA sequencing revealed remodeling of the HNSCC tumor microenvironment, which may correlate with improved clinical outcomes. This trial met the pre-specified primary endpoint, demonstrating a high pCR rate with promising efficacy and manageable toxicity in locally advanced HNSCC.

Date: 2025
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DOI: 10.1038/s41467-025-59865-1

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