eligibility_summary
Eligibility: Signed consent, adults 18–75 with pancreatic adenocarcinoma, R0/R1 resection, no neoadjuvant therapy, ECOG 0–1, life expectancy >12 mo, pre‑chemo CA19‑9 <100 U/mL, adequate organ/marrow, WOCBP: negative test/contraception. Exclude: borderline resectable, recurrence/metastasis, malignant ascites, IBD/obstruction/severe diarrhea, hypersensitivity/long‑term anti‑allergy, autoimmune, recent stroke/TIA or MI, unstable cardiac disease, recent immunomodulators/transfusion/EPO/G‑/GM‑CSF, tumor vaccines, immunodeficiency, other trial, noncompliance, investigator judgment.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: XH001, a personalized mRNA neoantigen cancer vaccine (biologic), sequentially combined with either ipilimumab (anti-CTLA-4 monoclonal antibody) or sintilimab (anti-PD-1 monoclonal antibody), plus chemotherapy (gemcitabine + capecitabine, antimetabolites). Mechanisms: XH001 delivers patient-specific tumor neoantigens to dendritic cells, enhancing MHC I/II presentation and priming/expanding tumor-specific CD8+ cytotoxic and CD4+ helper T cells. Ipilimumab blocks CTLA-4 to augment T-cell priming/expansion in lymph nodes, sintilimab blocks PD-1 to reinvigorate exhausted effector T cells in the tumor microenvironment. Gemcitabine and capecitabine inhibit DNA/RNA synthesis to debulk micrometastases and may increase antigen release. Targets/pathways: dendritic cells/APCs, antigen presentation, CD8+/CD4+ T-cell activation, CTLA-4 and PD-1 checkpoints, and tumor cells presenting neoantigens. Adjuvant setting after resected pancreatic cancer.