eligibility_summary
Eligible: Adults 19–80 with HBsAg-positive HCC scheduled for resection (≥6 weeks away) or listed for liver transplant, able to understand the trial and provide written consent. Exclude: significant non‑HBV illness, ineligible for resection/LT, other malignancy, HCV RNA+ or HIV coinfection, hepatic decompensation, HBIG allergy, pregnancy or lactation.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Intervention: Hepatect CP (hepatitis B immune globulin, HBIG) — an IV human polyclonal anti-HBs IgG (passive immunotherapy/biologic) given preoperatively for at least 6 weeks until liver resection or transplant. Mechanisms of action: neutralizes circulating HBV virions and subviral HBsAg particles to lower HBsAg and mitigate HBsAg-driven immunosuppression, can be internalized by hepatocytes to inhibit HBsAg/virion secretion, engages Fc-mediated ADCC via Fc-gamma receptors to recruit NK/other effector cells to kill HBV-infected hepatocytes, preclinical data indicate direct anti-tumor activity on HBV-HCC tumor-initiating cells, reducing proliferation/self-renewal and stemness (e.g., OCT4). Targets: HBsAg/SVPs, HBV-infected hepatocytes, immune effector pathways (ADCC), and HBV-related HCC tumor-initiating cells. Aim: reduce HBsAg and slow tumor progression pre-surgery.