Denosumab Strategy for Liver Cancer With Bone Metastases

Starting soon · Phase 2

Conditions studied: Hepatocellular Carcinoma (HCC), Bone Metastases

In brief

This study will evaluate whether starting denosumab early, together with a locked uniform PD-1-based systemic therapy, can reduce skeletal-related events and delay worsening bone pain compared with a delayed/rescue bone-modifying strategy in patients with hepatocellular carcinoma and bone metastases. Participants will be randomly assigned in a 1:1 ratio to receive either early denosumab plus the same PD-1-based systemic therapy or the same systemic therapy with no routine prophylactic bone-modifying agent at baseline and rescue treatment only when predefined triggers occur. The primary outcome is skeletal-related event-free survival. Secondary outcomes include time to first skeletal-related event, pain outcomes, quality of life, intrahepatic antitumor activity at Week 12, progression-free survival, overall survival, and safety.

Key facts

Study ID

NCT07537972

Run by

Tongji Hospital

People needed

50

Starts

2026-05-01

Expected to finish

2029-06-30

Last updated by the study team

2026-04-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 be deferred
• Active autoimmune disease or need for systemic immunosuppressive treatment, except for low-risk conditions judged acceptable by the investigator
• Life-threatening bone complication within 4 weeks before randomization that is not stabilized, including unresolved spinal cord compression or clinically significant spinal instability
• Active infection, including uncontrolled bacterial or fungal infection, active tuberculosis, or other condition judged unsafe for systemic treatment
• Symptomatic or uncontrolled central nervous system metastases
• Pregnancy or breastfeeding, or refusal to use effective contraception when applicable
• Known severe hypersensitivity to denosumab or any study-related treatment component
• Another active malignancy, poor compliance, or any condition judged by the investigator to make study participation unsuitable

Where it is running

• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China

Full record on ClinicalTrials.gov

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