eligibility_summary
Inclusion: 18–70, gastric/GEJ adenocarcinoma, one unresectable factor (e.g., P1/CY1, paraaortic LN, limited liver, ovarian), no prior systemic therapy, HER2 IHC 2+/3+, measurable, ECOG 0–1, ≥6‑mo life expectancy, adequate organs. Exclusion: other active cancer, drug allergy, recent systemic therapy/unresolved AEs, immune disorders/immunosuppression, recent thrombosis/bleeding, major CV disease/infection, unrecovered surgery, pregnancy/lactation or no contraception, investigator decision.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II single-arm conversion therapy in unresectable HER2-overexpressing gastric cancer tests: 1) Disitamab vedotin (RC48), an anti-HER2 antibody–drug conjugate delivering the microtubule-disrupting payload MMAE, it binds HER2 (ERBB2) on tumor cells, is internalized, releases MMAE to induce mitotic arrest and cell death, and may enhance ADCC. 2) Sintilimab, a PD-1 monoclonal antibody immune checkpoint inhibitor that blocks PD-1 to restore antitumor T-cell activity. 3) S-1 (tegafur/gimeracil/oteracil), an oral fluoropyrimidine chemo, tegafur generates 5-FU, inhibiting thymidylate synthase and DNA/RNA synthesis, gimeracil inhibits DPD, oteracil limits GI toxicity. 4) Intraperitoneal paclitaxel (taxane) for peritoneal metastases, stabilizing microtubules to block mitosis. Targets/pathways: HER2 on tumor cells, PD-1/PD-L1 on T cells/tumor, DNA synthesis, microtubules. Aim: tumor shrinkage to enable surgery.