eligibility_summary
Inclusion: Adults 18–69 with resectable high‑risk HNSCC (oral/oro-/hypopharynx/larynx, AJCC8: HPV− III–IVA or non‑oro HPV+ III–IVB), no prior HNSCC tx, measurable disease, ECOG 0–1, adequate labs, consent/contraception. Exclusion: prior checkpoint/EGFR/T‑cell therapy, autoimmune disease or recent immunosuppression, active HBV/HCV/HIV/TB or serious infection/live vaccine <4 wks, pregnancy/lactation, excluded stages: T1/2 or N0/1, T4b/N3 oral/larynx/hypopharynx, p16− oropharynx, peptic ulcer.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II, single-arm neoadjuvant trial in operable locally advanced HNSCC testing: 1) Toripalimab—anti-PD-1 IgG4 monoclonal antibody (immune checkpoint inhibitor), and 2) Cetuximab—anti-EGFR IgG1 monoclonal antibody. Regimen: 3 neoadjuvant cycles of toripalimab+cetuximab → surgery → adjuvant radiotherapy or chemoradiotherapy (cisplatin if high-risk) → toripalimab consolidation. Mechanisms: Toripalimab blocks PD-1/PD-L1 signaling on activated T cells, restoring antitumor cytotoxicity. Cetuximab inhibits EGFR on tumor cells, suppressing downstream MAPK and PI3K/AKT pathways, and induces antibody-dependent cellular cytotoxicity (ADCC) via NK cells. Targets: PD-1–expressing T lymphocytes, EGFR-overexpressing HNSCC cells, NK cell Fc-mediated killing, EGFR-RAS/RAF/MEK/ERK and PI3K/AKT signaling, broader tumor immune microenvironment. Aim: synergistic antitumor effect to improve pathologic response and outcomes.