eligibility_summary
Eligible: consent, age 18–75, ECOG 0–1, histologically confirmed gastric/GEJ adenocarcinoma, stage T3–4 N+ M0 (AJCC), measurable disease (RECIST 1.1), adequate organ function. Exclude: metastases or unresectable disease, current investigational study/device, major surgery <30d, active autoimmune needing systemic tx in past 2y, active HBV/HCV, MI/unstable angina/CHF within 12m, psych/substance issues, live vaccine <30d.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II neoadjuvant trial in resectable gastric/GEJ adenocarcinoma. Interventions: - Cadonilimab (AK104): bispecific IgG monoclonal antibody checkpoint inhibitor blocking PD-1 and CTLA-4 to activate effector T cells and diminish Treg-mediated suppression. - AK117: anti-CD47 monoclonal antibody blocking the CD47–SIRPalpha “don’t eat me” signal to boost macrophage phagocytosis and antigen presentation. - Chemotherapy: SOX (S-1 = tegafur-gimeracil-oteracil, an oral 5-FU prodrug combo inhibiting thymidylate synthase, plus oxaliplatin, a platinum DNA crosslinker) and FLOT components (5-FU antimetabolite, oxaliplatin, docetaxel, a microtubule-stabilizing taxane). Targets/pathways: PD-1 and CTLA-4 on T cells/Tregs, CD47 on tumor/hematopoietic cells engaging SIRPalpha on macrophages, DNA synthesis/repair (5-FU, S-1, oxaliplatin) and microtubules (docetaxel) in proliferating tumor cells.