eligibility_summary
Adults with unresectable locally advanced, recurrent, or metastatic gastric/GEJ adenocarcinoma, CLDN18.2+, ECOG 0–1, suitable for 1st-line chemo‑immunotherapy, adequate labs, and life expectancy ≥3 months. Exclude CNS mets/meningitis, significant ascites/pleural effusions/uncontrolled third‑space fluid, other cancers ≤5 yrs, candidates for anti‑HER2, prior anti‑CLDN18.2/PD‑1 or recent therapy (<4 wks), and pregnant/lactating or not using contraception.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Drugs/interventions: ASKB589 (anti‑CLDN18.2 monoclonal antibody), CAPOX chemotherapy (capecitabine + oxaliplatin), and a PD‑1 inhibitor (sintilimab or tislelizumab, anti‑PD‑1 monoclonal antibodies). Mechanisms: ASKB589 binds claudin 18.2 on gastric/GEJ tumor cells, promoting immune‑mediated cytotoxicity (ADCC/CDC). Capecitabine (prodrug of 5‑FU) inhibits thymidylate synthase, blocking DNA synthesis in proliferating cells. Oxaliplatin forms DNA crosslinks, inducing apoptosis. Sintilimab/tislelizumab block PD‑1 to reactivate exhausted T cells. Targets: CLDN18.2‑positive tumor cells, PD‑1 checkpoint on T cells, DNA replication/repair pathways in rapidly dividing tumor cells. Population: first‑line advanced unresectable CLDN18.2+ gastric/GEJ adenocarcinoma.