eligibility_summary
Adults 18–75 with ECOG 0–1, predicted survival ≥12 weeks, adequate organ function, and inoperable/advanced/metastatic gastric or gastroesophageal adenocarcinoma. No prior systemic therapy (neo/adjuvant allowed if relapse >6 months). HER2 IHC 0–3+. Must consent. Exclude: active CNS mets, active HBV/HCV/HIV, other malignancy within 5 years (except certain in situ/thyroid cancers), hypersensitivity to ADC or PD-(L)1, noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II/III first-line study in locally advanced/metastatic gastric/GEJ cancer across HER2-high, -intermediate/low, and -negative cohorts. Interventions: RC48-ADC (disitamab vedotin, anti-HER2 antibody–drug conjugate carrying MMAE, a microtubule inhibitor, also mediates ADCC/bystander killing) + toripalimab (anti–PD-1 immune checkpoint inhibitor) combined with CAPOX (capecitabine+oxaliplatin) or with trastuzumab (anti-HER2 mAb), comparators are toripalimab+CAPOX ± trastuzumab. Targets/mechanisms: HER2 on tumor cells (RC48-ADC, trastuzumab), PD-1 on T cells (toripalimab) to restore antitumor immunity, MMAE disrupts microtubules, oxaliplatin induces DNA crosslinks/immunogenic cell death, capecitabine→5-FU inhibits thymidylate synthase. Pathways/cells: HER2 signaling, PD-1/PD-L1 axis, proliferating tumor cells (DNA/microtubules), immune effector cells via ADCC.