NCT07537972Not yet recruitingPhase 2
Denosumab Strategy for Liver Cancer With Bone Metastases
Early Denosumab Plus a Uniform PD-1-Based Systemic Therapy Versus Delayed/Rescue Bone-Modifying Strategy in Hepatocellular Carcinoma With Bone Metastases: A Single-Center Prospective Randomized Controlled Exploratory Study
Source: ClinicalTrials.gov · Last updated 17 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 12 Apr 2026
- Start date
- May 2026
- Primary completion date
- May 2029
- Lead sponsor
- Tongji Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07537972
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 50
- From May 2026 to the primary completion date, May 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
- Life-threatening bone complication within 4 weeks before randomization that is not stabilized, including unresolved spinal cord compression or clinically significant spinal instability
Other illness
- Active autoimmune disease or need for systemic immunosuppressive treatment, except for low-risk conditions judged acceptable by the investigator
- Active infection, including uncontrolled bacterial or fungal infection, active tuberculosis, or other condition judged unsafe for systemic treatment
- 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
Other
- Uncorrected hypocalcemia or severe vitamin D deficiency that cannot be corrected promptly
- Symptomatic or uncontrolled central nervous system metastases
- Pregnancy or breastfeeding, or refusal to use effective contraception when applicable
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.