eligibility_summary
Adults 18–75 with HER2+ (IHC 2+/3+) gastric/GEJ adenocarcinoma, cT3–4aN1–3M0, resectable, no prior systemic therapy, ECOG 0–1, life expectancy ≥6 months, adequate organ function, agree/fit for radical surgery, contraception required. Exclude: recent other cancer, active bleed, concurrent trials, prior anti‑HER2/PD‑1/PD‑L1/L2, recent immuno/Chinese antitumor meds, active autoimmune, recent steroids, transplants, drug allergy, unresolved AEs, HIV, active HBV/HCV, recent live vaccine, pregnancy/lactation, serious disease, or per investigator.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Phase II, single-arm perioperative therapy for resectable, HER2-overexpressing gastric/GEJ adenocarcinoma. Interventions and mechanisms: 1) Disitamab vedotin (RC48) – antibody-drug conjugate targeting HER2, delivers MMAE (microtubule inhibitor) to HER2+ tumor cells, causing microtubule disruption and apoptosis, may also mediate ADCC. 2) Sintilimab – anti–PD-1 monoclonal antibody, blocks PD-1 on T cells to restore antitumor immunity by relieving PD-1/PD-L1 checkpoint inhibition. 3) XELOX chemotherapy – Oxaliplatin (platinum DNA crosslinker) plus Capecitabine (oral 5-FU prodrug, antimetabolite inhibiting thymidylate synthase), inducing DNA damage and impairing DNA synthesis. Targeted cells/pathways: HER2-overexpressing tumor cells, PD-1 pathway on T cells, tumor cell microtubules, DNA replication/repair pathways (crosslinking) and thymidylate synthase-dependent nucleotide synthesis.