eligibility_summary
Adults 18–75 with histologically confirmed gastric/EGJ adenocarcinoma, HER2+ or HER3+ (FISH amp), post-R0 resection, stage II–III, ECOG 0–1, adequate labs, able to comply/consent. Exclude: other recent malignancy or trial, prior anti‑HER2 neoadjuvant, active autoimmune disease or immunosuppression, CNS mets, major cardiac disease, proteinuria, pregnancy/lactation (contraception required), transplant, pneumonitis/ILD/IBD, TB, active HBV/HCV/HIV, substance/psychiatric issues, effusions, immunodeficiency.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II, single-arm adjuvant trial in resected stage II–III HER2-positive gastric/GEJ cancer tests serplulimab + trastuzumab + SOX (oxaliplatin + tegafur). Drugs/mechanisms: • Serplulimab: human IgG4 anti–PD-1 immune-checkpoint monoclonal antibody, blocks PD-1 on T cells from PD-L1/PD-L2, reactivating anti-tumor T-cell responses. • Trastuzumab: humanized IgG1 anti-HER2 monoclonal antibody, binds HER2 on tumor cells, inhibits HER2 signaling (PI3K/AKT, MAPK), reduces dimerization, and triggers NK cell–mediated ADCC. • Oxaliplatin: platinum cytotoxic, DNA crosslinker causing apoptosis of proliferating cells. • Tegafur: oral prodrug of 5-FU (antimetabolite), inhibits thymidylate synthase and disrupts RNA/DNA. Targets/pathways: PD-1 on T lymphocytes, HER2 receptor on tumor cells and downstream PI3K/AKT/MAPK, DNA replication in rapidly dividing cells, FcγR-mediated ADCC via NK cells.