eligibility_summary
Adults 18–75 with unresectable/recurrent/metastatic gastric or GEJ adenocarcinoma (HER2 positive or low) after failing first-line chemo, ECOG 0–2, >12-week survival, measurable disease, adequate marrow/organ/cardiac/renal/pulmonary/coagulation function, recent limited RT allowed. Exclude prior checkpoint therapy, active bleeding, symptomatic CNS mets, significant effusions/ascites, autoimmune/transplant, active HBV/HCV/HIV/TB, recent major surgery, uncontrolled CV/thromboembolism, immunosuppression, pregnancy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Single-arm phase 2 trial in second-line advanced gastric/GEJ adenocarcinoma with HER2-positive or low HER2 tests Disitamab Vedotin (RC48) plus Sintilimab. Disitamab Vedotin is an anti-HER2 antibody–drug conjugate with MMAE, it binds HER2 on tumor cells, is internalized, and releases MMAE to inhibit microtubules, causing mitotic arrest/apoptosis, the antibody may also trigger Fc-mediated ADCC. Sintilimab is an anti-PD-1 IgG4 monoclonal antibody that blocks PD-1/PD-L1 interactions to restore cytotoxic T-cell activity. Targets/pathways: HER2 on tumor cells, microtubule polymerization, Fc/ADCC (NK cells), and the PD-1/PD-L1 immune checkpoint on T cells.