eligibility_summary
Adults 18–70 with newly diagnosed, resectable primary HNSCC (AJCC 8th: T2N2–3M0 or T3–4N0–3M0), PS 0–1, measurable disease (RECIST 1.1), normal organ function by labs, surgery-eligible, and consented. Exclude: severe allergy to mAbs/PD-1/PD-L1/PD-L2/CTLA-4, autoimmune/neurologic disease, unresectable/metastatic, coagulopathy/anticoagulation, severe heart/lung dysfunction, prior checkpoint inhibitors, immunosuppression/steroids, HIV/HBV/HCV, recent anti-tumor herbs, pregnancy/breastfeeding.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Single-arm phase II neoadjuvant study in resectable locally advanced HNSCC testing: 1) Cetuximab (chimeric IgG1 anti-EGFR monoclonal antibody): blocks EGFR signaling (RAS/MAPK, PI3K/AKT), inhibits proliferation, and mediates NK cell–driven ADCC against EGFR+ tumor cells. 2) Zimberelimab (humanized IgG4 anti–PD-1 monoclonal antibody): releases PD-1 checkpoint to reinvigorate tumor-infiltrating T cells and enhance cytotoxic immunity. 3) Cisplatin (platinum chemotherapy): forms DNA crosslinks causing replication stress and apoptosis. 4) A taxane (docetaxel per registry, title notes nab‑paclitaxel): stabilizes microtubules, arresting mitosis. Targeted cells/pathways: EGFR on tumor epithelial cells, PD-1 on T cells (PD-1/PD-L1 axis), DNA damage/repair pathways, microtubule machinery, engagement of innate effectors via ADCC. The goal is cytoreduction and immune priming before surgery.