eligibility_summary
Adults 18–75 with metastatic, path‑confirmed CRC after ≥2 prior lines, prior effective anti‑EGFR (cetuximab/panitumumab) with >4 mo since last dose, MSS/pMMR, RAS/BRAF WT, ECOG 0–1, measurable disease, life ≥3 mo, adequate marrow/organ function, negative pregnancy test, consent. Exclude recent other cancers, serious illness/infection, recent EGFR or TAS‑102, allergy, pregnancy/lactation, brain mets, malabsorption/IBD, recent trials, HIV/HPV/syphilis, active HBV/HCV.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 3 randomized, double-blind trial in third-line+ metastatic colorectal cancer (MSS/pMMR, RAS/BRAF wild-type) tests: 1) Nimotuzumab: humanized IgG1 monoclonal antibody (biologic) targeting EGFR, blocks ligand binding and receptor activation, inhibiting downstream EGFR-RAS-RAF-MEK-ERK and PI3K-AKT signaling, may elicit ADCC against EGFR-expressing tumor cells. 2) Trifluridine/tipiracil (TAS-102): oral cytotoxic chemotherapy, trifluridine is a thymidine analog incorporated into DNA, disrupting replication, tipiracil is a thymidine phosphorylase inhibitor that prevents trifluridine degradation and prolongs exposure. Targets: EGFR-positive colorectal cancer cells reliant on EGFR signaling, key pathways: EGFR signaling cascades and DNA synthesis/replication.