eligibility_summary
Eligibility: ≥18, ECOG 0–1, resectable HER2+ (IHC3+ or IHC2+/FISH>2.0) esophageal/GEJ/gastric adenocarcinoma, adequate organs (ANC ≥1500, Plt ≥100k, Hb ≥8, CrCl ≥50, bili ≤1.5×ULN, AST/ALT ≤2.5×ULN, albumin >3, INR/PT/aPTT <1.5×ULN unless therapeutic). Contraception required. Exclude: metastatic or prior tx, prior anti‑PD‑1/PD‑L1/CTLA‑4/HER2, LVEF <50%, immunosuppressed, active TB/HIV/HBV/HCV, CNS mets, pneumonitis/infection, autoimmune <3y (exceptions), live vaccine, pregnancy, noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06123338: Single-arm phase 2 peri-operative study in resectable HER2+ esophagogastric cancer testing pembrolizumab + trastuzumab with chemotherapy (primarily FLOT: 5‑FU or capecitabine, oxaliplatin, docetaxel), then maintenance pembrolizumab + trastuzumab to 1 year. Drug types/mechanisms: pembrolizumab—anti–PD-1 monoclonal antibody (checkpoint inhibitor) restoring cytotoxic T-cell function, trastuzumab—anti-HER2 IgG1 monoclonal antibody blocking HER2 signaling and mediating ADCC, 5‑FU/capecitabine—fluoropyrimidine antimetabolites inhibiting thymidylate synthase/DNA synthesis, oxaliplatin—platinum DNA crosslinker, docetaxel—taxane stabilizing microtubules. Targets: PD-1/PD-L1 pathway on T cells/TME, HER2/ERBB2 on tumor cells, NK cell Fcγ engagement (ADCC), DNA synthesis/repair and mitotic spindle in proliferating tumor cells.