Purpose: This study aimed to assess the antitumor activity and safety of neoadjuvant chemotherapy combined with PD-1 inhibitor camrelizumab in patients with locally advanced head and neck squamous cell carcinoma (HNSCC). Patients and Methods: In this single-center, single-arm, phase 2 trial, patients with resectable stage III–IVB HNSCC received chemotherapy [albumin-bound paclitaxel 260 mg/m2 (or docetaxel 75 mg/m2) plus cisplatin 75 mg/m2] and camrelizumab 200 mg on day 1 of each 21-day cycle for three cycles, followed by surgery, and adjuvant radiotherapy. Co-primary end points were pathological complete response (pCR) rate and safety. Results: Thirty patients were enrolled and completed the neoadjuvant therapy, with an objective response rate (ORR) of 96.7% (29/30). Twenty-seven patients underwent surgery without delay, with an R0 resection rate of 92.6% (25/27). The clinical to pathological downstaging rate was 100% (27/27). The pCR rate was 37.0% [95% confidence interval (CI), 19.4%–57.6%], and the major pathological response (MPR) rate was 74.1% (95% CI, 53.7%–88.9%). The median follow-up duration was 16.1 months (range, 8.3–28.5), and the disease-free survival rate at 12 months was 95.8% (95% CI, 73.9%–99.4%). Grade 3 neoadjuvant therapy–related adverse events included rash (1; 3.3%), pruritis (1; 3.3%), and thrombocytopenia (1; 3.3%), and no grade 4 or 5 treatment-related events occurred. The most common surgical complication was delayed wound healing (5; 18.5%). Conclusions: Neoadjuvant chemotherapy plus camrelizumab for locally advanced HNSCC showed high ORR, pCR, and MPR rates, with an acceptable safety profile. These data support further evaluation of neoadjuvant chemoimmunotherapy for the treatment of locally advanced HNSCC.

中文翻译：

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新辅助化学免疫疗法治疗局部晚期头颈鳞状细胞癌：单臂 2 期临床试验

目的：本研究旨在评估新辅助化疗联合PD-1抑制剂卡瑞利珠单抗对局部晚期头颈鳞状细胞癌（HNSCC）患者的抗肿瘤活性和安全性。患者和方法：在这项单中心、单臂、2 期试验中，可切除的 III-IVB 期 HNSCC 患者接受化疗[白蛋白结合紫杉醇 260 mg/m2（或多西他赛 75 mg/m2）加顺铂 75 mg/m2]。 m2] 和卡瑞利珠单抗 200 mg，每个 21 天周期的第 1 天服用 3 个周期，然后进行手术和辅助放疗。共同主要终点是病理完全缓解（pCR）率和安全性。结果：30 例患者入组并完成新辅助治疗，客观缓解率（ORR）为 96.7%（29/30）。27名患者立即接受了手术，R0 切除率为 92.6% (25/27)。临床病理降期率为100%（27/27）。pCR 率为 37.0% [95% 置信区间 (CI)，19.4%–57.6%]，主要病理缓解 (MPR) 率为 74.1%（95% CI，53.7%–88.9%）。中位随访时间为 16.1 个月（范围为 8.3-28.5），12 个月时的无病生存率为 95.8%（95% CI，73.9%-99.4%）。3 级新辅助治疗相关不良事件包括皮疹（1 例；3.3%）、瘙痒症（1 例；3.3%）和血小板减少症（1 例；3.3%），未发生 4 级或 5 级治疗相关事件。最常见的手术并发症是伤口愈合延迟（5；18.5%）。结论：新辅助化疗联合卡瑞利珠单抗治疗局部晚期 HNSCC 显示出较高的 ORR、pCR 和 MPR 率，且安全性可接受。