eligibility_summary
Adults ≥18 with unresectable/metastatic gastric or GEJ adenocarcinoma, treatment‑naïve or ≥6 mo after adjuvant, ECOG 0–1, >3‑mo life expectancy, adequate organ function, measurable lesion, consent. Exclude: unstable CNS mets, prior checkpoint therapy, autoimmune disease or ILD, recent trials, immunosuppression, live vaccine or surgery, immunodef/transplant, active infections incl HBV/HCV/TB, heart disease, uncontrolled HTN, recent thrombosis, psychiatric/substance abuse, pregnancy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II single-arm trial in metastatic gastric cancer testing sintilimab (anti–PD‑1 monoclonal antibody) with a modified FLOT: nab‑paclitaxel (albumin-bound paclitaxel), oxaliplatin, and 5‑FU, maintenance capecitabine + sintilimab (later S‑1 ± sintilimab). In HER2‑positive patients, trastuzumab is added. Mechanisms: sintilimab blocks the PD‑1 checkpoint to reinvigorate tumor‑reactive T cells, nab‑paclitaxel (taxane) stabilizes microtubules causing mitotic arrest, oxaliplatin (platinum) forms DNA crosslinks, 5‑FU/capecitabine/S‑1 (fluoropyrimidines) inhibit thymidylate synthase and impair DNA/RNA synthesis, trastuzumab (anti‑HER2 mAb) inhibits HER2 signaling and induces ADCC. Targets/pathways: PD‑1 on T cells (PD‑1/PD‑L1 axis), HER2 receptor, microtubule dynamics, DNA crosslink/repair pathways, and thymidylate synthase–dependent DNA synthesis, NK‑cell–mediated ADCC.