eligibility_summary
Inclusion: 18–75, pathologic resectable locally advanced hypopharyngeal SCC (AJCC 8 T3–4aN0–3bM0) needing total laryngectomy, measurable, no prior therapy, ECOG 0–1, OS ≥6 mo, adequate organs, HBV DNA <500 IU/mL, HCV−, consent/contraception. Exclude: other cancers, prior RT/chemo/immuno/targeted, recent trials, CV/CNS, uncontrolled HTN, arrhythmia/QTc, proteinuria, active autoimmune/allergy, steroids/immunosupp., HIV/TB, HBV high/HCV+, psych/substance, recent live vax, pregnancy, unsafe conditions.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: Neoadjuvant TPC—toripalimab (anti–PD-1 IgG4 monoclonal antibody), cetuximab (anti-EGFR chimeric IgG1 mAb), and platinum chemotherapy (cisplatin or carboplatin, DNA crosslinking cytotoxics), followed by surgery and adjuvant radiotherapy/chemoradiotherapy. Mechanisms of action: Toripalimab blocks the PD-1/PD-L1 checkpoint to reinvigorate exhausted cytotoxic T cells and enhance antitumor immune responses. Cetuximab binds EGFR on tumor cells, inhibiting downstream RAS/RAF/MEK/ERK and PI3K/AKT signaling to reduce proliferation and survival, and mediates ADCC via NK cells. Cisplatin/carboplatin create DNA crosslinks, inducing apoptosis and immunogenic cell death, increasing antigen presentation. Radiotherapy induces tumor DNA damage and can augment immune priming. Targets/cells: PD-1 on T cells, PD-L1 on tumor/immune cells, EGFR on hypopharyngeal SCC cells, DNA integrity/repair pathways in tumor cells, immune effector cells (T cells, NK cells).