eligibility_summary
Eligible: adults ≥18 with life expectancy ≥12 wks, left-sided stage IV RAS/BRAF WT, MSS mCRC (non-appendiceal/anal), measurable disease, ECOG 0–1, no prior systemic therapy for advanced/metastatic (adjuvant ≤6 mo counts), adequate labs, negative pregnancy test/contraception, not in other trials. Exclude: other active cancers, GI bleeding risk, recent (≤12 mo) thromboembolic/cardiac events, prolonged antibiotics/unexplained fever, uncontrolled effusions, unresolved ≥Gr2 AEs, ILD/uncontrolled disease, HIV/active HBV/HCV, drug allergy, pregnancy/lactation, inadequate contraception, other serious illness.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05959356 tests: 1) Cetuximab (chimeric IgG1 monoclonal antibody, anti-EGFR) + envafolimab (anti–PD-L1 antibody) combined with mFOLFOXIRI (irinotecan, oxaliplatin, 5‑FU + leucovorin) vs 2) Cetuximab + mFOLFOX6 or FOLFIRI, in first-line unresectable left-sided RAS/BRAF WT, MSS metastatic colorectal cancer. Mechanisms: cetuximab blocks EGFR to inhibit MAPK/ERK and PI3K/AKT signaling and can mediate ADCC, envafolimab blocks PD-L1 to restore PD-1+ T‑cell activity, irinotecan inhibits topoisomerase I, oxaliplatin forms DNA crosslinks, 5‑FU (potentiated by leucovorin) inhibits thymidylate synthase and RNA. Targets: EGFR on colorectal tumor cells, DNA replication in rapidly dividing cancer cells, and the PD-1/PD-L1 checkpoint in the tumor microenvironment. Primary endpoint: PFS. Phase II, randomized, China.