eligibility_summary
Include: 18–75, unresectable/metastatic gastric or GEJ adenocarcinoma, recurrence >6 mo after (neo)adjuvant, measurable disease, ECOG 0–1, life ≥3 mo, adequate organs/coagulation, LVEF ≥50%, contraception, ≥14‑day washout after local therapy. Exclude: hypersensitivity, autoimmune, CNS mets, bleeding/ulcer, active HIV/HBV/HCV/TB, prior PD‑1/PD‑L1/CTLA‑4/VEGFR or recent steroids, uncontrolled cardiac/HTN/diabetes/liver/ILD, neuropathy ≥2, recent thrombosis/major surgery, significant effusions, malnutrition/psychiatric, other cancers, pregnancy, other trials, oral/PICC issues.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Umbrella phase Ib/II, first-line for unresectable advanced gastric/GEJ adenocarcinoma, genotype-guided: 1) HER2+: IBI315 (bispecific antibody anti–PD-1/anti‑HER2) + oxaliplatin (platinum DNA crosslinker) + capecitabine (oral 5‑FU prodrug, antimetabolite), maintenance IBI315. 2) CLDN18.2+: TQB2450 (anti‑PD‑L1 monoclonal antibody) + TST001 (anti‑Claudin18.2 mAb with enhanced ADCC/CDC) + oxaliplatin + capecitabine, maintenance TQB2450+TST001. 3) HER2–/CLDN18.2–: TQB2450 + anlotinib (small‑molecule multi‑TKI: VEGFR/FGFR/PDGFR/c‑KIT, anti‑angiogenic) + oxaliplatin + capecitabine, maintenance TQB2450+anlotinib. Targets/pathways: PD‑1/PD‑L1 checkpoint on T cells/tumor/immune cells, HER2 and Claudin18.2 on tumor cells (direct targeting, ADCC/CDC), VEGF/FGF/PDGF angiogenesis in endothelial/stromal cells, DNA synthesis/repair (platinum, TS inhibition).