eligibility_summary
Incl: adults 18–75 with measurable advanced GI cancer after ≥4 cycles 1st‑line therapy, ECOG 0–1, expected survival ≥6 mo, adequate organ function, LVEF ≥50%, and tumor tissue/seq for neoantigen analysis, contraception. Excl: recent other cancer/surgery/therapy, no neoantigen targets, transplant, immunosuppression, CNS mets, active infection, significant autoimmune/immune deficiency, major cardiopulmonary disease or uncontrolled HTN, symptomatic effusions/ascites, severe allergy, vulnerable/unsuitable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06026800: Phase 1, single-arm study in advanced digestive system cancers testing iNeo-Vac-R01, a biological (personalized therapeutic mRNA vaccine) encoding patient-specific tumor neoantigens, given by IH injection after ≥4 cycles of standard first-line therapy. Mechanism: the mRNA is taken up by antigen-presenting cells, translated into neoantigen proteins, processed and presented via MHC I/II to prime and expand neoantigen-specific T cells, driving tumor cell killing. Targets: dendritic cell antigen presentation pathways, activation of CD8+ cytotoxic T lymphocytes and CD4+ helper T cells, TCR-mediated recognition of neoantigen peptides on tumor cells within the tumor microenvironment.