eligibility_summary
Adults with resected stage III or high‑risk stage II colon (incl intraperitoneal rectal) adenocarcinoma, ECOG ≤1 (71–75 yrs ECOG 0), ctDNA+, no mets, adequate organ function. Part I: 4–12 wks post‑surgery, target arm: HER2+, RAS wt, LVEF ≥50. Part II: after 3–6 mo FP/oxaliplatin adjuvant, ctDNA+. Exclude: residual tumor, other cancers <5y, DPYD def (P1), uncontrolled infection, bleeding/coag, major CV dz, recent trials, pregnancy, target arm: ≥G2 diarrhea, chronic liver dz, active HBV/HCV.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05062889 tests ctDNA-guided adjuvant/post‑adjuvant therapy in resected stage III/high‑risk II colon cancer. Interventions: • FOLFOX or CAPOX (cytotoxic chemotherapy): 5‑fluorouracil (antimetabolite, thymidylate synthase inhibitor), leucovorin (folinic acid, enhances 5‑FU–TS binding), oxaliplatin (platinum DNA crosslinker), or capecitabine (oral 5‑FU prodrug). • FOLFOXIRI adds irinotecan (topoisomerase I inhibitor). • Post‑adjuvant trifluridine/tipiracil (TAS‑102, antimetabolite: trifluridine incorporates into DNA, tipiracil inhibits thymidine phosphorylase to prevent trifluridine degradation). • Target-driven cohort: trastuzumab (HER2 monoclonal antibody blocking ERBB2 signaling and mediating ADCC) + tucatinib (oral selective HER2 tyrosine kinase inhibitor) with FOLFOX. Targets/pathways: DNA synthesis/repair (TS, DNA crosslinks, Topo I, DNA incorporation), and HER2→MAPK/PI3K in HER2+ RAS‑WT tumor cells, aims to eradicate ctDNA‑detected micrometastases.