eligibility_summary
Adults 18–75 with recurrent/metastatic NPC, first‑line, inoperable, EGFR+, measurable (RECIST 1.1), ECOG 0–2, ≥3‑mo survival, adequate marrow/renal/hepatic labs, negative pregnancy test (women). Exclude: RT/chemo/immunosuppressants/mAbs/EGFR‑TKI/anti‑angiogenic ≤6 mo, trial/major surgery <30 d, uncontrolled comorbidities, active cancer, IO contraindications (autoimmune, HIV/HBV/HCV, ILD, CNS mets, allo‑tx), allergy, ≥G2 neuropathy/hearing loss, pregnant/lactating or no contraception.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions and mechanisms: • Nimotuzumab – humanized IgG1 monoclonal antibody against EGFR (HER1/ErbB1), blocks ligand binding and downstream MAPK/ERK and PI3K/AKT signaling, inhibits proliferation, and can induce ADCC. • Toripalimab – humanized IgG4 monoclonal antibody checkpoint inhibitor targeting PD‑1, restores T‑cell activation and antitumor immunity. • Gemcitabine – antimetabolite (deoxycytidine analog), inhibits ribonucleotide reductase and DNA synthesis. • Cisplatin – platinum chemotherapeutic, forms DNA crosslinks leading to apoptosis. Cells/pathways targeted: • EGFR‑positive nasopharyngeal carcinoma cells. • PD‑1 on T cells and the PD‑1/PD‑L1 immune checkpoint in the tumor microenvironment. • DNA replication and repair pathways in tumor cells. • Potential engagement of NK cells via ADCC from anti‑EGFR therapy.