eligibility_summary
Consented adults 18-85 with histologically confirmed RAS wild-type, BRAF V600E-negative metastatic/unresectable colorectal adenocarcinoma, ECOG 0-1, and at least one measurable lesion (RECIST 1.1), needing first-line therapy. Exclude: prior CRC chemo or anti-EGFR, systemic therapy/radiation/surgery/other trials within 4 weeks (biopsy allowed), severe skin disease needing systemic treatment, serious infection, uncontrolled pleural/pericardial/peritoneal effusions.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase IIb, multicenter, open-label randomized study in first-line RAS wild-type advanced colorectal cancer. Interventions: Ametumumab (fully human anti-EGFR monoclonal antibody) + anti-PD-1 mAb (toripalimab) + FOLFIRI vs Ametumumab + FOLFIRI vs Cetuximab (chimeric anti-EGFR mAb) + FOLFIRI, schedules compare weekly vs Q2W ametumumab. FOLFIRI components/mechanisms: irinotecan (topoisomerase I inhibitor), 5-fluorouracil (antimetabolite inhibiting thymidylate synthase), leucovorin (enhances 5-FU). Mechanisms/targets: anti-EGFR mAbs block EGFR on tumor epithelial cells, inhibiting downstream MAPK/PI3K signaling and proliferation, anti-PD-1 blocks PD-1 on T cells to restore antitumor cytotoxicity, irinotecan induces DNA damage, 5-FU impairs DNA synthesis. Targets/pathways: EGFR pathway in RAS WT CRC cells, PD-1/PD-L1 immune checkpoint on T cells, DNA replication machinery in dividing tumor cells.