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eligibility_summary
Adults ≥18 with left-sided metastatic colorectal adenocarcinoma: initially RAS-mutant/BRAF-WT, progressed after 5-FU/oxaliplatin/irinotecan (≤3 months on irinotecan), post–second-line ctDNA RAS/BRAF-WT, RECIST-measurable, adequate marrow, liver (Child-Pugh A), renal, ECOG 0–2, life expectancy >3 months, consent. Exclude right-sided, dMMR/MSI-H, ctDNA RAS/BRAF+, bleeding/coagulopathy, serious CV/CNS disease, infection, other recent cancers, pregnancy, or noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05962502 is a single-arm phase II trial testing cetuximab plus irinotecan as third-line therapy for left-sided metastatic colorectal cancer with ctDNA-defined NeoRAS wild-type status after prior fluoropyrimidine/oxaliplatin/irinotecan. Drugs and mechanisms: Cetuximab (ERBITUX) is a chimeric IgG1 anti-EGFR monoclonal antibody (targeted biologic) that blocks EGFR ligand binding, inhibits EGFR→RAS/RAF/MEK/ERK signaling, promotes receptor internalization, and can induce ADCC. Irinotecan is a camptothecin prodrug chemotherapy converted to SN-38 that inhibits topoisomerase I, causing DNA damage and apoptosis. Targets/pathways: EGFR on tumor epithelial cells, downstream MAPK pathway contingent on RAS/BRAF wild type, DNA replication machinery via TOP1. Primary endpoint: objective response rate, secondary: PFS, OS, safety.