eligibility_summary
Adults ≥18 with resectable gastric/GEJ adenocarcinoma (cT3–4aN+, M0), histologically confirmed, no prior therapy, HER2 IHC 1–3+, ECOG 0–1, LVEF ≥50%, adequate marrow, liver, renal, coagulation, contraception/consent. Exclude: need periop RT, unrecovered recent major surgery, bleeding, perforation/fistula, obstruction/malabsorption, ≥G2 neuropathy, active HBV/HCV/HIV or serious infection, recent live vaccine, major cardiac/thrombo events, uncontrolled comorbidities, lung/autoimmune disease, other recent cancers, transplant, study-drug allergy, DPD deficiency, recent immunotherapy/trials, pregnancy/lactation, noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II, open-label, randomized perioperative trial in resectable HER2‑expressing (IHC 1+/2+/3+) gastric/GEJ adenocarcinoma compares: (1) Disitamab vedotin (RC48, anti‑HER2 antibody–drug conjugate delivering MMAE, a microtubule inhibitor) + toripalimab (anti‑PD‑1 monoclonal antibody) + XELOX, (2) disitamab vedotin + toripalimab, (3) XELOX (capecitabine, oral 5‑FU prodrug antimetabolite inhibiting thymidylate synthase, + oxaliplatin, platinum DNA crosslinker). Targets/pathways: HER2 receptor on tumor cells (ADC binding/internalization), microtubules (MMAE), PD‑1 checkpoint on T cells (reinvigorates antitumor immunity), DNA crosslinking/damage response (oxaliplatin), and nucleotide synthesis via thymidylate synthase (capecitabine/5‑FU). Aim: enhance tumor cell kill and immune activation perioperatively.