本研究旨在探讨Pembrolizumab联合化疗作为新辅助治疗在可切除局部晚期头颈部鳞状细胞癌（LA-HNSCC）患者中的疗效和安全性。在这项前瞻性、单臂、单中心临床试验中，符合纳入标准的患者接受200mg的Pembrolizumab联合75mg/m2的顺铂和175mg/m2的紫杉醇作为术前新辅助治疗。随后进行手术和术后辅助治疗。主要终点指标为术后病理学完全缓解（pCR）率。所有统计分析使用SPSS 26进行。共纳入了22位患者。原发病灶的位置分布情况为：下咽15例（68.2%），咽腔6例（27.3%），口腔1例（4.5%）。术后pCR率为36.4%（8/22），无手术延迟因不良药物反应。喉功能保留率为90.9%（20/22）。迟发性伤口愈合是主要的手术并发症，发生率为22.7%（5/22）。中位随访时间为9.5个月，只有1例患者（4.55%）出现局部复发。可切除LA-HNSCC的术前Pembrolizumab联合化疗具有较高的pCR率且对手术安全性无显著影响。该治疗发现可以提高喉功能保留率。然而，新辅助免疫治疗在LA-HNSCC的长期预后方面的影响需要进一步研究。版权所有© 2023 王，桂，陆，何，李，刘，刘和王。

This study aimed to explore the efficacy and safety of pembrolizumab combined with chemotherapy as neoadjuvant therapy in patients with resectable locally advanced head and neck squamous cell carcinomas (LA-HNSCCs).In this prospective, single-arm, single-centre clinical trial, patients meeting the inclusion criteria were treated with preoperative neoadjuvant therapy with 200 mg pembrolizumab combined with 75 mg/m2 cisplatin and 175 mg/m2 paclitaxel. This was followed by surgery and postoperative adjuvant therapy. The primary endpoint was the postoperative pathological complete response (pCR) rate. All statistical analyses were performed using SPSS 26.A total of 22 patients were enrolled. The location of primary lesion showed: hypopharynx were 15 (68.2%), oropharynx were 6 (27.3%) and oral cavity was 1 (4.5%). The postoperative pCR rate, was 36.4% (8/22), and there was no delay to surgery due to adverse drug reactions. The rate of laryngeal function preservation was 90.9% (20/22). Delayed wound healing was the main surgical complication, with an incidence of 22.7% (5/22). The median follow-up time was 9.5 months, and only 1 patient (4.55%) suffered a regional recurrence.Preoperative treatment with pembrolizumab and chemotherapy in resectable LA-HNSCC has a high pCR rate with no significant impact on surgical safety. This treatment was found to increase the rate of laryngeal function preservation. However, the effects of neoadjuvant immunotherapy on long-term prognosis in LA-HNSCCs require further study.Copyright © 2023 Wang, Gui, Lu, He, Li, Liu, Liu and Wang.