eligibility_summary
Eligibility: Adults 18–70 with HBV-positive advanced HCC after failure of ≥2nd-line tx (PD-1, chemo, anti-VEGF). HBsAg+, HBV DNA any. ECOG 0–1, life ≥3 mo, adequate labs (Hb ≥80, ANC >1.5, Plt ≥80×10^9/L, bili ≤1.5×ULN, ALT/AST ≤2.5×ULN or ≤5× if liver mets, CrCl ≥60 mL/min, LVEF ≥50%). Consent/compliance. Exclude: trial <4 wks, other active cancers, major cardiac disease, pregnancy, active TB/bacterial/fungal, HIV or HCV, psych/substance issues, active autoimmune, unsafe comorbidity.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT05738447 (Phase I, single-arm). Intervention: HBV mRNA vaccine (biologic, therapeutic mRNA immunotherapy) given intramuscularly with dose escalation (starting 20 µg), weekly x4 then a 1‑month booster. Mechanism: mRNA is taken up by host cells and translated into HBV antigens, which are presented via MHC I/II to prime and expand HBV-specific immunity—primarily cytotoxic CD8+ T cells, helper CD4+ T cells, and potentially antibody responses—aimed at eliminating HBV antigen–expressing hepatocellular carcinoma cells. Targeted cells/pathways: antigen-presenting cells (especially dendritic cells) for antigen presentation, activation of HBV-specific CTLs, MHC I/II antigen processing pathways, broader tumor- and virus-directed adaptive immune responses in HBV+ HCC.