eligibility_summary
Eligible: Adults 20–80 with primary gastric adenocarcinoma, pathologic stage II–III, HER2+ (IHC/FISH), after R0 gastrectomy with D2 lymphadenectomy, ECOG 0–1, expected survival >6 months, no contraindications with normal labs and ECG. Exclude: stage I or IV, unable to undergo R0+D2, multiple primaries, serious CV/respiratory/renal/hepatic disease or poorly controlled HTN/diabetes/psychiatric illness, prior chemo, radiotherapy, immunotherapy, or targeted therapy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2 adjuvant trial in resected stage II–III HER2+ gastric cancer compares serplulimab + trastuzumab + chemotherapy vs chemotherapy alone. Interventions/mechanisms: • Serplulimab: anti–PD-1 monoclonal antibody (immune checkpoint inhibitor) that blocks PD-1 on T cells, restoring cytotoxic T-cell activity by inhibiting the PD-1/PD-L1 pathway. • Trastuzumab: anti-HER2 (ERBB2) monoclonal antibody that binds HER2 on tumor cells, inhibits HER2 signaling and induces ADCC. • Chemotherapy: capecitabine or S-1 (fluoropyrimidines, inhibit thymidylate synthase/DNA synthesis) plus oxaliplatin (platinum, DNA crosslinker). Targets/pathways: PD-1 on T cells, PD-1/PD-L1 immune checkpoint, HER2/ERBB2 signaling (PI3K/AKT, MAPK) on tumor cells, DNA replication in proliferating tumor cells.