eligibility_summary
Include: ≥18 with HER2‑negative gastric adenocarcinoma, CLDN18.2+, peritoneal‑only metastasis, ECOG 0–1, >3‑mo survival, adequate bone marrow/liver/renal function, no prior tumor resection. Exclude: non‑peritoneal mets, pregnancy/lactation, other recent malignancy, prior ICI or CLDN18.2 therapy, serious cardiac/CNS disease, GI obstruction/malabsorption, >G1 neuropathy, transplant immunosuppression/recent steroids, active infections (HIV/HBV/HCV/TB), renal impairment, DPD deficiency, paclitaxel allergy, active autoimmunity, recent MI/arrhythmia.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2 single-arm regimen for CLDN18.2-positive gastric cancer with peritoneal metastasis combines: 1) Cadonilimab (bispecific monoclonal antibody, immune checkpoint inhibitor targeting PD-1 and CTLA-4) to block inhibitory signaling, reactivate effector T cells, and reduce Treg suppression, 2) LM-302 (anti-Claudin 18.2 monoclonal antibody) to bind CLDN18.2 on tumor cells and trigger immune-mediated cytotoxicity (ADCC/CDC), 3) S-1 (oral fluoropyrimidine, tegafur/gimeracil/oteracil) delivering 5-FU to inhibit thymidylate synthase and DNA/RNA synthesis, with DPD inhibition to boost exposure, 4) Intraperitoneal paclitaxel (microtubule stabilizer) to induce mitotic arrest in peritoneal tumor deposits. Targets: PD-1/PD-L1 and CTLA-4 pathways on T cells (CD8+ T cells, Tregs), CLDN18.2 on gastric tumor cells, thymidylate synthase/DNA synthesis, and microtubules in dividing cancer cells.