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