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

Authors

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
Wen Jiang

Publication Date

5-17-2025

Journal

Nature Communications

DOI

10.1038/s41467-025-59865-1

PMID

40382318

PMCID

PMC12085655

PubMedCentral® Posted Date

5-17-2025

PubMedCentral® Full Text Version

Post-print

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.

Keywords

Humans, Male, Female, Middle Aged, Squamous Cell Carcinoma of Head and Neck, Antibodies, Monoclonal, Humanized, Neoadjuvant Therapy, Cisplatin, Aged, Head and Neck Neoplasms, Adult, Albumin-Bound Paclitaxel, Antineoplastic Combined Chemotherapy Protocols, Treatment Outcome, Paclitaxel

Published Open-Access

yes

Recommended Citation

Liu, Zhigang; Wang, Dong; Li, Guanjun; et al., "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" (2025). Faculty, Staff and Student Publications. 4548.
https://digitalcommons.library.tmc.edu/uthgsbs_docs/4548