eligibility_summary
Eligibility: 18–75, ECOG 0–1, metastatic/recurrent gastric or GEJ adenocarcinoma, EGFR IHC2+/3+, progressed after 1st‑line chemo (±anti‑HER2/IO), ≥1 RECIST lesion, life ≥12 wks, adequate organs, contraception/negative pregnancy test, consent. Exclude: recent paclitaxel/anti‑EGFR, other trials/major surgery, CNS mets, other active cancers, severe bleeding, serious cardiac/diabetes/psych disease, drug allergies, unresolved ≥G3 irAEs, uncontrolled effusions/≥G2 neuropathy, immunodeficiency, active HBV/HCV, HIV/syphilis/uncontrolled infection, pregnancy, any unsafe condition.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05978050 is a randomized, double-blind, placebo-controlled phase III trial in recurrent/metastatic gastric or esophagogastric junction adenocarcinoma with EGFR overexpression (IHC 2+/3+). Interventions: nimotuzumab + paclitaxel vs placebo + paclitaxel. Nimotuzumab is a humanized IgG1 monoclonal antibody against EGFR/HER1 (ErbB1), it blocks ligand binding and receptor activation, inhibiting downstream EGFR signaling (RAS/RAF/MEK/ERK and PI3K/AKT) and may induce ADCC. Paclitaxel is a taxane cytotoxic chemotherapy that stabilizes microtubules, causing mitotic arrest and apoptosis. Targets: EGFR-overexpressing tumor cells and proliferating cancer cells, pathways affected include EGFR/ErbB signaling and cell-cycle/mitotic spindle dynamics. Primary endpoint: overall survival, secondary: PFS, ORR, DOR, DCR, PRO, safety.