eligibility_summary
Eligible: 18–75, pathology‑confirmed operable stage III–IVb HNSCC (non‑nasopharyngeal, oropharynx: p16− III–IVb, p16+ III), no prior therapy, ECOG 0–1, life ≥6 mo, no contraindications to immuno/radiochemo/surgery, willing for surgery, adequate organ function, contraception, consented. Exclude: prior checkpoint therapy, autoimmune needing immunosuppression, HIV, active HBV/HCV, severe mAb allergy, major cardiac events ≤6 mo, live vaccine ≤4 wks, allo transplant, pregnant/breastfeeding, other cancer <5 y (except select cured).
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 3 randomized, open-label trial in resectable LA-HNSCC testing neoadjuvant toripalimab + albumin-bound paclitaxel + carboplatin with or without cetuximab, then surgery and adjuvant toripalimab, control gets surgery with standard postoperative RT ± cisplatin only. Mechanisms/types: Toripalimab—anti-PD-1 IgG4 monoclonal antibody (immune checkpoint inhibitor) restoring T-cell activation, Cetuximab—anti-EGFR IgG1 monoclonal antibody blocking EGFR signaling (MAPK/PI3K) and mediating ADCC, Nab-paclitaxel—taxane microtubule stabilizer causing mitotic arrest, Carboplatin/Cisplatin—platinum agents forming DNA crosslinks leading to apoptosis, Radiotherapy—ionizing radiation causing DNA double-strand breaks. Targets: PD-1/PD-L1 axis on effector T cells, EGFR on tumor cells, microtubule dynamics, tumor DNA damage/repair pathways, NK-cell engagement via ADCC.