Abstract
Induction chemo-immunotherapy has emerged as a potential treatment option for locoregionally advanced nasopharyngeal carcinoma (LANPC). This study aimed to evaluate the efficacy and safety of camrelizumab combined with modified TPF (nab-paclitaxel, cisplatin, and S-1) as induction chemo-immunotherapy in LANPC. Patients with stage T1-4N2-3M0 NPC who received induction chemo-immunotherapy were enrolled from July 2023 to May 2024. They underwent three cycles of chemo-immunotherapy, including camrelizumab 200 mg on day 1, nab-paclitaxel 260 mg/m(2) on day 1, cisplatin 25 mg/m(2) on days 1-3, and oral S-1 40-60 mg twice daily from days 1 to 14, every 21 days. The primary endpoint was the complete response (CR) rate, while secondary endpoints included the safety and objective response rate (ORR). A total of 30 patients were enrolled, with 29 (96.7%) completing three cycles of induction chemo-immunotherapy. The CR rate was 41.4% (12/29), achieving the predefined endpoint. The CR rate for the primary nasopharyngeal tumor and cervical lymph nodes was both 65.5% (19/29). Seventeen patients achieved a partial response (PR), resulting in an ORR of 100%. Grade 3 or 4 chemotherapy-related adverse events occurred in 26.6% of patients. Immune-related adverse events of any grade were reported in 20 (66.7%) patients, including reactive cutaneous capillary endothelial proliferation in 10 patients (40.0%), all of which were Grade 1 or 2. One patient (3.5%) experienced a Grade 3 rash. No treatment-related deaths occurred. Our study suggests that induction chemo-immunotherapy of camrelizumab plus modified TPF demonstrated an excellent CR rate and an acceptable safety profile in patients with LANPC. Trial Registration: ChiCTR240008603.