eligibility_summary
Eligible: adults ≥18 with histologically confirmed SCC of tongue/floor of mouth/gingiva/buccal, NCCN stage III–IVA, ECOG PS 0–1, measurable RECIST 1.1 lesion, adequate organ function, tissue available. Exclude: autoimmune disease, serious comorbidities, other malignancy, CNS mets/meningitis, uncontrolled effusions, recent major surgery/trauma or thrombosis, substance abuse/psychiatric illness, severe uncontrolled disease, conflicting meds, other trial <4 wks, vaccines <4 wks.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II single-arm conversion therapy in unresectable oral cavity SCC tests: 1) Toripalimab—anti‑PD‑1 monoclonal antibody (immune checkpoint inhibitor) that blocks PD‑1 to restore cytotoxic T‑cell activity. 2) Cetuximab—anti‑EGFR chimeric monoclonal antibody that inhibits EGFR signaling and can induce ADCC via NK cells/macrophages. 3) Cisplatin—platinum cytotoxic that forms DNA crosslinks, causing replication stress and apoptosis. 4) 5‑Fluorouracil—pyrimidine analog antimetabolite that inhibits thymidylate synthase and disrupts DNA/RNA synthesis. Targeted cells/pathways: PD‑1/PD‑L1 axis on T cells/tumor cells, EGFR pathway on tumor cells, DNA replication/repair pathways via cisplatin, thymidylate synthase–dependent nucleotide synthesis via 5‑FU, primarily affecting rapidly dividing tumor cells.