eligibility_summary
Adults 18–70 with advanced HCC (CNLC IIb–IIIb) progressed after guideline therapy, pathology‑confirmed, ≥1 RECIST lesion, GPC3+ by IHC, tissue available, ECOG 0–1, life ≥3 mo, Child‑Pugh A/B, adequate organ function, consent and contraception. Exclude: pregnancy, active HCV/HIV/syphilis or HBV DNA ≥500 IU/mL, prior anti‑GPC3 or transplant, recent therapy/trial/vaccine, CNS mets, major cardiac/autoimmune/infectious/immunodeficiency risks, severe allergy, other recent cancers, serious psych disease.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial tests an autologous cellular therapy: GPC3-targeted CAR-T cells delivered via hepatic arterial infusion (single-arm, Phase I/II, dose-escalation from 1×10^6 to 6×10^6 cells/kg, then RP2D). Mechanism: patient T cells are engineered with a CAR containing an anti-GPC3 scFv, co-stimulatory domain(s) (4-1BB/CD28), and CD3ζ, plus added immune microenvironment–activating elements designed to enhance CAR-T activation/proliferation and recruit/activate APCs and bystander immune effectors, aiming to overcome the HCC tumor microenvironment. Optional lymphodepletion uses fludarabine (purine analog antimetabolite) and cyclophosphamide (alkylating agent) to deplete lymphocytes and aid engraftment. Targets: GPC3 on HCC cells (a GPI-anchored heparan sulfate proteoglycan influencing Wnt/Hedgehog/FGF signaling) and broader TME remodeling.