eligibility_summary
Adults ≥18 with recurrent/metastatic HNSCC of oral cavity/oropharynx(p16)/larynx/hypopharynx, CUP ok, 2nd line post-pembrolizumab±chemo, chemo-free ≥3 mo, ECOG 0–2, measurable progression, adequate labs, life exp ≥12 wks, contraception/consent. Exclude: CNS mets, ≥G2 neuropathy, significant cardiac disease, recent therapy/surgery/trial, live vaccine, recent malignancy, hypersensitivity, uncontrolled illness/psychiatric, pregnant/breastfeeding, bleeding tumor, ILD, prior transplant.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Single-arm Phase II trial in recurrent/metastatic HNSCC after failure of pembrolizumab ± chemotherapy tests PCC: paclitaxel (cytotoxic taxane) + carboplatin (platinum cytotoxic) + cetuximab (chimeric IgG1 anti-EGFR monoclonal antibody), with cetuximab maintenance. Mechanisms: paclitaxel stabilizes microtubules, inducing G2/M arrest and apoptosis, carboplatin forms DNA intra/interstrand crosslinks causing DNA damage–mediated cell death, cetuximab blocks EGFR ligand binding and downstream signaling (RAS/RAF/MEK/ERK, PI3K/AKT), inhibits proliferation, and triggers ADCC via NK cells. Targets/pathways: EGFR on HNSCC tumor cells, microtubule dynamics, DNA replication/repair, and immune effector ADCC. Primary focus: objective response rate in second-line.