eligibility_summary
Adults 18–75 with advanced HCC (BCLC B/C or CNLC IIA–IIIB), measurable lesion, failed/intolerant to ≥2nd‑line systemic therapy or recurrence after local therapy (≥4 wks), HBsAg+ or history, HLA‑A11:01, Child‑Pugh <7, ECOG ≤1, adequate labs, >6‑mo survival, contraception, no alcohol. Exclude: tumor load >70%, main PVTT, decomp cirrhosis, mod–severe ascites, HIV/syphilis, HBV DNA ≥1000 IU/mL, HCV RNA+, recent bleed/thrombosis, uncontrolled HTN, severe cardiac disease, prior cell/recent ICI/other therapy, pregnancy, or poor compliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Intervention: QY-1-T, a TCR-engineered T-cell therapy (TCR-T). Mechanism: patient T cells are genetically modified to express a TCR that recognizes HBV-derived peptide antigens presented by HLA-A11:01 on tumor cells, triggering TCR signaling, cytokine release, and MHC class I–restricted cytotoxic killing. Targets: HBV antigen–expressing hepatocellular carcinoma cells, key pathways include antigen presentation via HLA class I, TCR activation, and CD8+ effector (perforin/granzyme) functions. Population: HBV-associated advanced HCC, HLA-A11:01–positive. Regimen: step-up induction dosing followed by weekly maintenance infusions. Primary aim: assess safety and preliminary efficacy.