eligibility_summary
Key eligibility: Adults ≥18, ECOG 0–1, life expectancy ≥12 wks, resected gastric/GEJ/esophageal adenocarcinoma after FLOT, no metastases, HER2+ (IHC 3+ or 2+/ISH+) on surgical tissue, ctDNA+ 2–6 wks post‑op, LVEF ≥50%, adequate marrow/organ function, consent and contraception. Exclude: metastases, uncontrolled illness/infection, MI/CHF/QTc prolongation, ILD/pulmonary disease, live vaccines, unresolved tox, hypersensitivity, pregnancy, malignant effusions, prior anti‑HER2, HER2−/ctDNA−, DPD deficiency, recent investigational study.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II TRINITY tests adjuvant trastuzumab deruxtecan (T-DXd) plus capecitabine or 5-FU vs standard FLOT in resected HER2-positive gastric/GEJ/esophageal adenocarcinoma with postoperative ctDNA-defined minimal residual disease. Drugs/mechanisms: T-DXd is an antibody–drug conjugate (anti-HER2 monoclonal antibody linked to a topoisomerase I inhibitor, DXd), it binds HER2, blocks signaling, triggers ADCC, internalizes and releases DXd to induce DNA damage (bystander effect). Capecitabine (oral prodrug of 5-FU) and 5-FU are fluoropyrimidine antimetabolites inhibiting thymidylate synthase. FLOT: 5-FU (antimetabolite) + leucovorin (TS modulator), oxaliplatin (platinum DNA cross-linker), docetaxel (taxane microtubule stabilizer). Targets/pathways: HER2/ERBB2 on tumor cells, topo I–mediated DNA replication, thymidylate synthase, DNA cross-link repair, mitotic spindle—aimed at eradicating ctDNA+ MRD.