A Pilot Clinical Trial of Cetuximab Combined With Tislelizumab as Neoadjuvant Therapy for Locally Advanced Oral Squamous Cell Carcinoma
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.
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). 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.
The study provides evidence for a non‑chemotherapy neoadjuvant regimen using cetuximab (an EGFR‑targeted monoclonal antibody) and tislelizumab (an anti‑PD‑1 antibody) in locally advanced oral squamous cell carcinoma, offering a potential therapeutic option for patients who cannot tolerate standard cytotoxic chemotherapy.
Evidence level: Sejtvonalas. Laboratóriumi sejtekben vizsgálták.
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