A Pilot Clinical Trial of Cetuximab Combined With Tislelizumab as Neoadjuvant Therapy for Locally Advanced Oral Squamous Cell Carcinoma.

BACKGROUND: Chemotherapy-free neoadjuvant strategies remain undefined for patients with locally advanced oral squamous cell carcinoma (OSCC) who are medically unsuitable for conventional cytotoxic chemotherapy. METHODS: In this prospective single-arm pilot trial, 15 patients received two cycles of neoadjuvant tislelizumab plus cetuximab before planned surgery. The primary endpoint was major pathological response (MPR). RESULTS: All patients completed neoadjuvant treatment and underwent radiographic assessment. The objective response rate was 73.3%. Twelve patients underwent surgery; five achieved MPR and two achieved pathological complete response. At a median follow-up of 23 months, the 2-year event-free survival and overall survival rates were 66.0% and 78.3%, respectively. No treatment-related deaths occurred. CONCLUSIONS: Neoadjuvant cetuximab plus tislelizumab showed feasible delivery, encouraging antitumor activity, and acceptable safety in patients with locally advanced OSCC who were medically unsuitable for conventional cytotoxic chemotherapy.