在复发口腔癌（OCC）的救治手术后进行再次放射治疗的作用存在争议。我们评估了这一患者情况下辅助使用toripalimab（PD-1抗体）的疗效和安全性。在这个二期研究中，招募了经过救治手术的局部晚期既往受过放射治疗的OCC患者。患者每3周一次，持续12个月接受toripalimab 240mg的治疗，或与S-1口服合并使用4-6个疗程。主要终点为1年无进展生存率（PFS）。从2019年4月至2021年5月，共招募了20名患者。其中60%的患者有ENE或阳性切缘，80%在复发中被重新分期为IV期，80%之前接受过化疗治疗。对于CPS≥1的患者，1年PFS和总生存率（OS）分别为58.2%和93.8%，明显优于真实世界的对照组（P=0.001和0.019）。没有报告4-5级毒性反应，只有一名患者经历了3级免疫相关性肾上腺功能不足并停止治疗。CPS＜1、CPS 1-19和CPS≥20的患者1年PFS和OS显着不同（分别为P=0.011和0.017）。同时外周血B细胞比例也与6个月内的PD相关（P=0.044）。在复发、先前接受过放疗的OCC患者中，救治手术后辅助使用toripalimab或与S-1联合使用的PFS得到了改善，并且对于CPS较高和外周B细胞比例较高的患者观察到了良好的PFS。需要进一步进行随机试验。 © 2023作者。

The role of re-irradiation after salvage surgery for recurrent oral cavity cancer (OCC) is controversial. We evaluated the efficacy and safety of adjuvant toripalimab (PD-1 antibody) in this patient setting.In this phase II study, patients after salvage surgery with OCC occurring in an area of previously irradiated were enrolled. Patients received toripalimab 240 mg once every 3 weeks for 12 months, or combined with S-1 orally for 4-6 cycles. The primary endpoint was 1-year progression-free survival (PFS).Between April 2019 and May 2021, 20 patients were enrolled. Sixty percent patients had ENE or positive margins, 80% were restaged as stage IV, and 80% were previously treated with chemotherapy. The 1-year PFS and overall survival (OS) were 58.2%, and 93.8%, respectively, for patients with CPS ≥ 1, which was significantly better than those of the real-world reference cohort (p = 0.001 and 0.019). No grade 4-5 toxicities were reported, and only one patient experienced grade 3 immune related adrenal insufficiency and discontinued treatment. The 1-year PFS and OS were significantly different for patients with CPS < 1, CPS 1-19 and CPS ≥ 20 (p = 0.011 and 0.017, respectively). The peripheral blood B cell proportion was also correlated with PD in 6 months (p = 0.044).Adjuvant toripalimab or combine with S-1 after salvage surgery showed improved PFS compared with a real-world reference cohort in recurrent, previously irradiated OCC, and favorable PFS were observed in patients with a higher CPS and peripheral B cell proportion. Further randomized trials are warranted.© 2023 The Author(s).