eligibility_summary
Adults (≥18) with RAS/BRAF WT mCRC after 8 cycles first-line cetuximab+FOLFOX/FOLFIRI and disease control, measurable lesion or CR/NED, ECOG 0–1, adequate labs/organ function, life expectancy ≥12 wks, consent, protocol adherence, not in other trials. Exclude prior systemic beyond allowed, CNS mets, other active cancers, unresolved ≥G2 AEs, serious comorbidities, uncontrolled DM/HTN, major CV disease, HBV/HCV/HIV, autoimmune/transplant, recent surgery/radiation/therapy, pregnancy/lactation, no contraception.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Single-arm Phase 1b/2 trial testing triweekly cetuximab plus capecitabine as first-line maintenance for KRAS/BRAF wild-type metastatic colorectal cancer after induction therapy. Cetuximab: chimeric IgG1 monoclonal antibody (targeted therapy) against EGFR, blocks ligand binding to inhibit downstream signaling (RAS/RAF/MEK/ERK and PI3K/AKT) and can induce ADCC via NK cells against EGFR-expressing tumor cells. Capecitabine: oral fluoropyrimidine (antimetabolite) prodrug of 5-FU, converted in tumors to 5-FU to inhibit thymidylate synthase and disrupt RNA/DNA synthesis, killing proliferating cells. Targets: colorectal cancer cells with EGFR dependence and intact RAS/BRAF, key pathways include EGFR signaling and nucleotide synthesis/DNA replication. Includes 3+3 dose escalation to determine MTD/RP2D, capecitabine 2 weeks on/1 week off, cetuximab Q3W.