eligibility_summary
Adults 18–75 with resectable advanced digestive cancers (cholangiocarcinoma, pancreatic, HCC, gastric, colorectal), ECOG 0–1, ≥6‑month survival, adequate tumor tissue, organ function, LVEF ≥50%, and able to receive ≥4 cycles adjuvant therapy, contraception required. Exclude: recent other cancer/major surgery, no actionable neoantigens, transplants, recent anti‑tumor therapy, immunosuppression, recent vaccines, active infections, autoimmune disease, major CV/resp disease, effusions/ascites, substance abuse/allergy, vulnerable groups.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1, single-arm trial testing iNeo-Vac-R01, a personalized neoantigen mRNA cancer vaccine (biologic), given by injection every 21 days (up to 9 cycles) after surgery plus standard adjuvant therapy in resected digestive system cancers. Mechanism: patient-specific mRNA is taken up by antigen-presenting cells (e.g., dendritic cells), translated into neoantigen peptides, and presented via MHC class I/II to prime and expand tumor-specific T cells. Targets: dendritic cells/APCs for antigen processing and presentation, CD8+ cytotoxic and CD4+ helper T cells via TCR signaling, ultimate killing of tumor cells expressing the encoded neoantigens and establishment of immune memory.