Denosumab Strategy for Liver Cancer With Bone Metastases

Inclusion Criteria: * Age 18 to 75 years * Hepatocellular carcinoma confirmed by imaging and/or histology according to current institutional diagnostic standards * Bone metastasis confirmed by CT, MRI, bone scintigraphy, PET-CT, or pathology * ECOG performance status 0 to 1 * Child-Pugh class A or stable Child-Pugh B7 judged suitable for systemic treatment * At least 1 measurable intrahepatic lesion at baseline and planned initiation of a PD-1 inhibitor-based systemic therapy * Estimated life expectancy of at least 3 months * Adequate organ function according to protocol-defined laboratory criteria * Corrected serum calcium within the normal range, or corrected to protocol-defined range after calcium/vitamin D supplementation * Completed baseline oral/dental risk assessment and willingness to avoid nonessential invasive dental procedures during the study * Written informed consent and willingness to comply with study visits, questionnaires, sample collection, and follow-up Exclusion Criteria: * Prior treatment with PD-1, PD-L1, CTLA-4, or other immune checkpoint inhibitors * Receipt of denosumab or intravenous/oral bisphosphonates for tumor-related bone disease within 6 months before randomization * Uncorrected hypocalcemia or severe vitamin D deficiency that cannot be corrected promptly * Current or prior osteonecrosis of the jaw, jaw osteomyelitis, or high-risk dental condition requiring near-term extraction, implantation, or other invasive dental procedures that cannot …