eligibility_summary
Eligible: HER2+ (IHC3+/FISH) esophageal/EGJ adenocarcinoma after chemoradiation and R0 esophagectomy without path CR, 4–12 wks postop, T1N1–2 or T2–3N0–2 M0 at start, age ≥18, ECOG 0–1, LVEF ≥50%, adequate organs, pregnancy precautions. Exclude: major cardiac/QTc/arrhythmia, ILD/pulmonary disease, uncontrolled infection, active HIV/HBV/HCV, live vaccine, unresolved tox, hypersensitivity, active autoimmune disease/immunosuppression, other cancers <3y, drainable effusions, prior anti‑HER2/IO, pregnancy/breastfeeding, other anticancer therapy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II adjuvant trial in HER2+ esophageal/GEJ adenocarcinoma after chemoradiation and esophagectomy. Interventions: trastuzumab deruxtecan (Enhertu), an anti‑HER2 antibody–drug conjugate (humanized IgG1 trastuzumab linked to a topoisomerase I inhibitor, DXd), and nivolumab (Opdivo), a PD‑1–blocking IgG4 monoclonal antibody checkpoint inhibitor. Mechanisms: T‑DXd binds HER2 on tumor cells, is internalized, releases DXd to inhibit topoisomerase I causing DNA breaks and bystander killing, retains trastuzumab functions (ADCC, HER2 signaling blockade). Nivolumab blocks PD‑1 on T cells, restoring anti‑tumor cytotoxic T‑cell activity. Targets/pathways: HER2‑overexpressing tumor cells, HER2 signaling, DNA replication via topo I, PD‑1/PD‑L1 axis on tumor‑infiltrating lymphocytes in the tumor microenvironment. Both IV q3w for 12 months (T‑DXd with dose‑reduction tiers).