Two cycles of neoadjuvant therapy with low-dose radiotherapy, PD-1 inhibitor tislelizumab, albumin-bound paclitaxel, and cisplatin for resectable locally advanced head and neck squamous cell carcinoma (NeoRTPC02): A phase II, open-label, single-arm trial.

作者：Zhigang Liu, Dong Wang, Guanjun Li, Muhua Yi, Zhaoyuan Zhang, Guihua Zhong, Yingpeng Peng, Lizhong Liang, Jianpeng Li, Ye Liu, Jun Lai, Xiaofei Lv, Yongqiang Xu, Qiandan Liu, Zhi‐Qiang Wang, Zhutian Liu, Qinan Yang, Li Nie, Lei Jiao, Zhijie Liu, Zhigang Liu LDRT · 发表于：Journal of Clinical Oncology · 年份：2025 · DOI：10.1200/jco.2025.43.16_suppl.6039 · 被引用次数：1 · 研究领域：Head and Neck Cancer Studies、Lung Cancer Treatments and Mutations、Lung Cancer Diagnosis and Treatment

6039 Background: Despite standard treatments, mortality rates remain high in locally advanced head and neck squamous cell carcinoma (LA HNSCC). Neoadjuvant immunotherapy combined with chemotherapy has improved response rates, but further enhancement is needed. Recent studies suggest that low-dose radiotherapy (LDR) can reprogram the tumor microenvironment, reversing immune suppression and improving the efficacy of PD-1 inhibitors. This study aims to evaluate the safety and efficacy of neoadjuvant LDR combined with tislelizumab and chemotherapy in LA HNSCC. Methods: This was an open-label, single-arm, phase II clinical trial for patients with untreated, histologically confirmed stage III-IVB HNSCC. Patients received neoadjuvant low-dose radiotherapy (1 Gy/1F, days 1, 2, 8, and 15, Q3W) combined with tislelizumab (200 mg, day 1, Q3W), albumin-bound paclitaxel (100 mg/m², days 1, 8, and 15, Q3W), and cisplatin (25 mg/m², days 1, 8, and 15, Q3W) for two cycles. Afterward, patients underwent radical surgery approximately 4 weeks later. The primary endpoint was the pathological complete response (pCR) rate, while secondary endpoints included major pathological response (MPR) rate, ORR, R0 resection rate, safety, and treatment-related surgical delay rate. The exploratory endpoints were the 3-year progression-free survival and 3-year overall survival. To further investigate the underlying mechanisms of treatment effects, we used single-cell RNA sequencing (scRNA-seq) to explore how t...