eligibility_summary
Adults 18–75 with BCLC C HCC (imaging/histology), progressed after anti‑angiogenic + PD‑1 therapy, life expectancy ≥12 wks, Child‑Pugh A/B, consented. Exclude: severe HTN/cardiac disease, CNS tumor/other malignancy, uncontrolled immune/infection, HIV/syphilis, prior stem cell/organ transplant, severe allergy to immunotherapy/anti‑angiogenic drugs, bilirubin >2×ULN, GFR <60, serious effusions, UGIB, hepatic encephalopathy, pregnancy/lactation, investigator deem unsuitable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
NCT05962450 tests adding adoptive autologous invariant natural killer T (iNKT, Vα24+ T) cell therapy to PD-1 inhibitor plus regorafenib versus PD-1+regorafenib alone in progressed HCC. Interventions/mechanisms: • iNKT cells (cell therapy): recognize glycolipid antigens via CD1d, rapidly secrete IFN-γ and other cytokines, directly lyse tumor cells, activate NK and dendritic cells, and remodel the immunosuppressive microenvironment to overcome PD‑1 resistance. • PD-1 inhibitor (checkpoint antibody): blocks PD‑1/PD‑L1 signaling to reinvigorate exhausted T cells. • Regorafenib (oral multikinase TKI): inhibits VEGFR1‑3/TIE2, RAF, KIT, RET, PDGFR, FGFR, reducing angiogenesis and tumor growth. Targets/pathways: iNKT cells, T-cell reinvigoration via PD‑1 pathway, NK/DC activation, VEGF/VEGFR and RAF‑MAPK signaling, tumor endothelium, and HCC cells.