eligibility_summary
Consent, adults 18–75 with resected PDAC (NCCN resectable, no metastasis), R0/R1, EGFR+ by IHC, baseline KRAS/CDX-2 tested, adequate marrow/organ function, ECOG 0–1, expected survival ≥3 months, contraception if fertile. Exclude prior neoadjuvant/RT/systemic therapy, other active cancers, serious comorbidities/infections, postop delay >12 wks, CA199 >180 U/mL, drug allergy, HIV/syphilis or active HBV/HCV, investigator judged unsuitable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Single-arm phase II adjuvant study in resected EGFR-positive pancreatic ductal adenocarcinoma testing nimotuzumab plus nab-paclitaxel/gemcitabine (AG). Drugs/mechanisms: 1) Nimotuzumab—humanized IgG1 monoclonal antibody (targeted therapy) against EGFR, blocks ligand binding and receptor activation, inhibiting RAS–RAF–MEK–ERK and PI3K–AKT signaling, can induce antibody-dependent cellular cytotoxicity (NK cell–mediated). 2) Nab-paclitaxel—albumin-bound taxane cytotoxic, stabilizes microtubules causing mitotic arrest, with improved tumor delivery. 3) Gemcitabine—deoxycytidine analog antimetabolite, inhibits ribonucleotide reductase and incorporates into DNA, blocking synthesis. Targets/pathways: EGFR-overexpressing tumor cells, cell-cycle microtubules, DNA synthesis, and immune effector ADCC pathways.