eligibility_summary
Include: 18–60, GPC3+ primary HCC (pathology), BCLC A/B or CNLC Ib–IIIa, R0 resection/ablation + hepatic artery therapy (dose <12 wks post‑op, >7 d after), no residual/metastatic disease, no Vp4, ECOG 0–1, Child‑Pugh A/B≤7, LE>6 mo, antivirals if HBV/HCV. Excl: recurrence, unrecovered postop, encephalopathy, dialysis, uncontrolled effusions/ascites, recent bleed, recent Tx/trial/steroids, immune/autoimmune, allogeneic Tx, severe infection incl HIV/syphilis, serious organ/CV dz, pregnancy/lactation, contraception.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06088459 tests NWRD06, a biological naked DNA plasmid vaccine (genetic immunotherapy) delivered intramuscularly with electroporation (TERESA) after radical resection of GPC3-positive HCC. Dose-escalation (3+3): 1, 4, or 8 mg at weeks 0, 4, and 8. Mechanism: plasmid uptake drives in vivo expression of GPC3 antigen, enabling dendritic cell antigen presentation via MHC I/II and inducing GPC3-specific adaptive immunity—primarily CD8+ cytotoxic T cells and CD4+ helper responses, with potential antibody generation—to eradicate residual micrometastatic disease and establish immune memory. Target cells/pathways: GPC3-expressing HCC cells, activation of APCs, T-cell priming/effector cytotoxicity (IFN-γ–mediated), and antigen presentation pathways.