eligibility_summary
Inclusion: ≥18, new stage III–IVB HNSCC (oral/oro-/hypopharynx/larynx), EGFR 2–3+ by IHC/FISH, unresectable locally advanced or recurrent/metastatic, CPS≥1, cisplatin‑ineligible, measurable disease (RECIST 1.1), ECOG 0–1, life expectancy >3 mo, negative pregnancy test. Exclusion: platinum‑eligible, prior PD‑1/PD‑L1 or EGFR therapy, other trial <30 d, other malignancy <5 y (except cured in situ/superficial), autoimmune disease, immunodeficiency, live vaccine <30 d, major surgery <90 d, pregnant/lactating or no contraception, allergy, no consent.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial tests radiotherapy plus two biologics in cisplatin‑ineligible, locally advanced/unresectable HNSCC with EGFR positivity. Drugs: Nitozumab (type: humanized IgG1 monoclonal antibody against EGFR) and Sinilimab (type: human IgG4 monoclonal antibody against PD‑1). Mechanisms: Nitozumab binds EGFR on tumor cells, blocks ligand binding and downstream signaling (RAS/RAF/MEK/ERK, PI3K/AKT), promotes antibody‑dependent cellular cytotoxicity, and enhances radiosensitivity. Sinilimab inhibits PD‑1, restoring exhausted T‑cell function and antitumor immunity. Targets: EGFR‑overexpressing HNSCC cells and their EGFR signaling pathway, the PD‑1/PD‑L1 immune checkpoint on T cells and tumor/immune cells, effector CD8+ T cells and NK cell–mediated ADCC. Radiotherapy adds local DNA damage and antigen release, synergizing with EGFR and PD‑1 blockade.