eligibility_summary
Adults ≥18 with untreated, limited-stage oral SCC (AJCC8 T1N+M0 or T2–4 anyN M0), fit for radical therapy, ≥1 RECIST lesion, ECOG 0–1, adequate marrow/renal/hepatic function, controlled HBV/HCV allowed, contraception required. Exclude prior OSCC or PD‑1/PD‑L1 therapy, active autoimmune/infections (incl HIV/TB), brain mets, ILD/pneumonitis, recent major surgery/transplant, significant CV disease, high‑dose steroids, pregnancy/lactation, severe malnutrition/≥5% weight loss, neuropathy ≥2, recent live vaccine/other trials.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Single-arm phase II neoadjuvant trial in primary limited-stage oral squamous cell carcinoma testing toripalimab plus nimotuzumab before radical surgery or radiotherapy. Drugs/mechanisms: • Toripalimab—humanized IgG4 monoclonal antibody, PD-1 checkpoint inhibitor. Blocks PD-1 on T cells to prevent PD-L1/PD-L2–mediated suppression, restoring cytotoxic T-cell antitumor activity. • Nimotuzumab—humanized IgG1 monoclonal antibody against EGFR. Inhibits ligand binding and EGFR signaling (MAPK/ERK, PI3K/AKT), curbing proliferation and may promote ADCC. Targets: • Immune cells—PD-1+ activated T lymphocytes (tumor microenvironment), modulating the PD-1/PD-L1 axis. • Tumor cells—EGFR-overexpressing oral SCC cells and downstream proliferative/survival pathways, potential engagement of NK cells via ADCC. Regimen: toripalimab 240 mg IV q3wk + nimotuzumab 150 mg/m² q2wk for 2 cycles, then definitive local therapy per response.