eligibility_summary
Inclusion: Adults 18–75 with path-confirmed locoregionally recurrent oral/oropharyngeal SCC ≥16 wks post curative therapy, ECOG 0–1, survival ≥12 wks, eligible for salvage surgery, RECIST-measurable disease, any HPV (OPSCC tested), contraception, adequate organ/thyroid function, consent. Exclusion: distant mets, recent curative chemo/RT, prior checkpoint inhibitors, live vaccine ≤30 d or immunosuppressants ≤14 d, active infection/ILD/HBV/HCV/HIV, transplant, unresolved >G2 AEs, major CV disease/uncontrolled HTN, pregnancy/breastfeeding, psych/substance issues, other trial ≤30 d, otherwise unsuitable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Single-arm phase II in resectable, locally recurrent oral/oropharyngeal SCC. Neoadjuvant tislelizumab (anti-PD-1 IgG4 monoclonal antibody, immune checkpoint inhibitor), cetuximab (anti-EGFR IgG1 monoclonal antibody, targeted therapy), cisplatin (platinum cytotoxic, DNA crosslinker), and nab-paclitaxel (albumin-bound taxane, microtubule stabilizer), followed by salvage surgery, then adjuvant tislelizumab + cetuximab for ~6 months. Targets/mechanisms: Tislelizumab blocks PD-1 on exhausted T cells to restore antitumor immunity, cetuximab inhibits EGFR signaling (RAS/MAPK, PI3K/AKT) and mediates ADCC via NK cells, cisplatin induces DNA damage/apoptosis, nab-paclitaxel arrests mitosis via microtubule stabilization. Overall targets: PD-1/PD-L1 checkpoint, EGFR on tumor cells, DNA repair/replication, and mitotic machinery, engages T cells and NK cells.