eligibility_summary
Adults 18–75 with pathologically confirmed locally advanced PDAC without distant metastasis, no prior systemic therapy, candidate for nimotuzumab+NALIRIFOX, measurable disease (RECIST 1.1), adequate organ function, ECOG 0–1, expected survival ≥3 months, contraception, consent. Exclude refusal of chemo/surgery, other malignancy, major comorbidities/infections/effusions, major surgery or EGFR therapy <30 days, drug allergy, HIV/HPV/syphilis or active HBV/HCV, investigator judgment.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06429904 tests nimotuzumab plus NALIRIFOX in locally advanced pancreatic ductal adenocarcinoma. Interventions/mechanisms: Nimotuzumab is a humanized anti-EGFR IgG1 monoclonal antibody that blocks EGFR ligand binding/activation, suppressing MAPK/ERK and PI3K/AKT signaling and mediating antibody-dependent cellular cytotoxicity (ADCC). NALIRIFOX combines liposomal irinotecan (topoisomerase I inhibitor via SN-38), 5-fluorouracil (pyrimidine analog inhibiting thymidylate synthase and RNA/DNA synthesis), leucovorin (enhances 5‑FU’s TS inhibition), and oxaliplatin (platinum agent causing DNA crosslinks/apoptosis). Targets: EGFR on PDAC cells and its downstream pathways, DNA replication/repair in rapidly dividing tumor cells, innate immune effector cells (e.g., NK cells) via ADCC.