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eligibility_summary
Adults 18–80 with histologically/cytologically confirmed stage IV colorectal adenocarcinoma, unresectable or recurrent liver metastases, ≥1 measurable lesion (RECIST 1.1), any KRAS/NRAS/BRAF status, ECOG 0–1, adequate nonhepatic organ function, and able to comply. Excludes non-intestinal primaries, surgically resectable primary/metastases, severe allergies to study drugs, or serious respiratory/circulatory/urinary/hematologic disease.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial tests three regimens in unresectable colorectal liver metastases: 1) SOX chemotherapy: oxaliplatin (platinum DNA crosslinker cytotoxic) + S‑1 (tegafur/gimeracil/oteracil, oral 5‑FU prodrug, inhibits thymidylate synthase and RNA/DNA synthesis), 2) SOX + cetuximab (chimeric IgG1 anti‑EGFR monoclonal antibody blocking EGFR signaling, efficacy greatest in KRAS/NRAS/BRAF wild‑type tumors), 3) “Quintuple method”: SOX + cetuximab + folic acid (folate, enhances 5‑FU–TS ternary complex), vitamin A (retinoid, activates RAR/RXR to influence differentiation/apoptosis), metronidazole (nitroimidazole antibiotic, modulates gut microbiota/tumor microenvironment). Targets/pathways: tumor DNA crosslink repair/DNA damage response, thymidylate synthase/pyrimidine synthesis, EGFR→RAS/RAF/MEK/ERK signaling, retinoid receptor pathways, microbiome-associated effects.