eligibility_summary
Adults 18–80 with path-confirmed HER2+ (IHC3+ or 2+/FISH+) gastric/EGJ adenocarcinoma, cT2–T4b N± M0, ECOG 0–1, life ≥6 mo, adequate marrow, liver, renal, coagulation, cardiac (LVEF ≥55%), willing to provide biopsy/surgical tissue and blood/urine/feces, contraception required. Exclude prior GC therapy, other recent cancers, obstruction/bleeding, major cardiac disease, chronic diarrhea, active infection/TB, ILD, HIV/HBV/HCV, immunosuppression, severe allergy/autoimmunity, recent live vaccine, transplant, uncontrolled comorbidities.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Drugs/interventions: Toripalimab (anti-PD-1 IgG4 monoclonal antibody checkpoint inhibitor, blocks PD-1 to restore T-cell antitumor activity), Trastuzumab (anti-HER2/ERBB2 humanized IgG1 monoclonal antibody, inhibits HER2 signaling and mediates ADCC), and FLOT chemotherapy: 5-FU (antimetabolite, thymidylate synthase inhibitor), Leucovorin (reduced folate, potentiates 5-FU), Docetaxel (taxane, microtubule stabilizer causing mitotic arrest), Oxaliplatin (platinum, DNA crosslinker). Targeted cells/pathways: HER2-overexpressing gastric/EGJ adenocarcinoma cells via HER2 signaling (PI3K/AKT/MAPK), the PD-1/PD-L1 immune checkpoint on T cells/tumor cells to activate CD8+ T cells, and rapidly dividing tumor cells’ DNA synthesis and mitosis.