eligibility_summary
Eligibility: ≥65, volunteer with histo/cyto‑confirmed gastric or GEJ adenocarcinoma, HER2 IHC 3+ or 2+, no prior systemic therapy (adjuvant allowed if >6 mo and recovered), ≥1 RECIST lesion, ECOG 0–2, life expectancy ≥6 mo, adequate marrow/renal/hepatic/coagulation labs. Exclude: other active cancers, prior allo transplant, recent systemic therapy, immunodeficiency, drug allergy, serious infection, unrecovered surgery, pregnancy/lactation, inadequate contraception, or other safety concerns.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, single-arm first-line study in elderly HER2-overexpressing gastric/GEJ cancer testing: 1) Disitamab vedotin (RC48) — an anti-HER2 antibody–drug conjugate (ADC) linked to MMAE. Mechanism: binds HER2 (ERBB2) on tumor cells, internalizes, releases MMAE to inhibit microtubules, causing G2/M arrest and apoptosis, with possible bystander killing. 2) Sintilimab — a human IgG4 anti–PD-1 checkpoint inhibitor. Mechanism: blocks PD-1 on T cells, preventing PD-L1/PD-L2–mediated inhibition and restoring antitumor T-cell activity. Targets: HER2+ tumor cells, microtubules, and the PD-1/PD-L1 immune checkpoint on CD8+ T cells within the tumor microenvironment.