This phase II study evaluates the efficacy and safety of neoadjuvant chemoimmunotherapy consisting of camrelizumab (PD-1 inhibitor), paclitaxel, and carboplatin in patients with resectable locally advanced (Stage III-IVA) squamous cell carcinoma of the oral cavity and/or larynx.
Fifty patients will receive 3 cycles of therapy (camrelizumab 200 mg IV, paclitaxel 175 mg/m2 IV, carboplatin AUC6 IV, Day 1 every 21 days) followed by radical surgery 4-6 weeks later. Patients are then stratified to risk-adapted adjuvant therapy based on pathological findings (radiation or chemoradiation with cisplatin if adverse features present).
The primary endpoint is the pathological complete response (pCR) rate and major pathological response (MPR, \<10% viable tumor cells) rate at surgery. Secondary endpoints include objective response rate (ORR) by imaging (MRI/PET-CT), correlation of PET-CT metabolic response with pathological response, proportion requiring adjuvant chemoradiation, and 3-year event-free survival compared to historical controls.
Study period: 2026-2029.