eligibility_summary
Adults ≥18 with resectable, non‑metastatic HER2+ gastric/GEJ adenocarcinoma, ECOG 0–1, adequate organ function, no prior systemic therapy or tumor resection, consent and contraception. Exclude distant/retroperitoneal/mesenteric nodes, peritoneal carcinomatosis or adjacent‑organ invasion, cardiac dysfunction/QTc>500, recent major surgery/live vaccine/CSFs, immunodeficiency, active autoimmune/pneumonitis/infection, HIV/HBV/HCV, recent cancers, hypersensitivity/DPD issues, pregnancy, prior PD‑1/PD‑L1, recent investigational therapy, allogeneic transplant.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II, single-arm perioperative study in HER2+ localized esophagogastric adenocarcinoma. Interventions: pembrolizumab (anti–PD-1 IgG4 monoclonal antibody, immune checkpoint inhibitor), trastuzumab (anti‑HER2 IgG1 monoclonal antibody), and FLOT chemotherapy: docetaxel (taxane microtubule stabilizer), oxaliplatin (platinum DNA crosslinker), 5‑FU (pyrimidine analog antimetabolite inhibiting thymidylate synthase) with folinic acid (enhances 5‑FU). Given pre‑ and post‑op, then maintenance pembrolizumab+trastuzumab to 1 year. Mechanisms/targets: PD‑1/PD‑L1 axis on T cells to restore CD8+ antitumor activity, HER2/ERBB2 on tumor cells to block signaling and trigger ADCC via Fcγ receptors on NK/macrophages, microtubules (docetaxel), DNA crosslinks (oxaliplatin), thymidylate synthase/DNA synthesis (5‑FU). Exploratory: PD‑L1, MSI subtypes. Primary endpoints: DFS, pCR.