Hepatocellular Carcinoma (HCC)Phase 2NCT07537972
Denosumab Strategy for Liver Cancer With Bone Metastases
A Phase 2 study testing Denosumab, Sintilimab and Delayed/Rescue Bone-Modifying Strategy in people with Hepatocellular Carcinoma (HCC) and Bone Metastases, run by Tongji Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC), Bone Metastases
- What is being tested?
- Denosumab, Sintilimab and Delayed/Rescue Bone-Modifying Strategy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 30 Jun 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: 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
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.
Read the detailed description
This is a single-center, prospective, randomized, open-label, blinded-endpoint (PROBE) exploratory phase 2 strategy study in patients with hepatocellular carcinoma (HCC) and radiologically or pathologically confirmed bone metastases. A total of 50 participants will be randomized in a 1:1 ratio to either early denosumab plus a locked uniform PD-1-based systemic therapy or the same PD-1-based systemic therapy with a delayed/rescue bone-modifying strategy.
The study is designed to evaluate whether an early denosumab strategy can improve bone-related clinical outcomes in HCC with bone metastases. The key clinical question is not whether denosumab improves short-term intrahepatic radiographic response, but whether early RANKL inhibition can reduce or delay skeletal-related events, delay pain worsening, and improve quality of life when added to a uniform PD-1-based systemic therapy backbone.
The PD-1-based systemic therapy backbone must be locked before enrollment of the first participant and remain consistent throughout the study. Both study arms receive the same locked systemic regimen, standard supportive care, analgesic therapy, and clinically necessary local treatment for bone metastases. The only protocol-defined treatment difference between the two arms is whether denosumab is started at baseline.
Participants randomized to the experimental arm will receive denosumab 120 mg subcutaneously every 4 weeks, with correction of hypocalcemia before treatment initiation and calcium/vitamin D supplementation as indicated. Participants randomized to the control arm will not routinely receive prophylactic bone-modifying agents at baseline. Rescue bone-modifying therapy may be initiated when predefined triggers occur, such as impending or actual pathologic fracture, spinal cord compression or worsening spinal instability, worsening bone pain despite standard management, rapidly progressive bone destruction judged to substantially increase skeletal-related event risk, or malignant hypercalcemia.
The primary endpoint is skeletal-related event-free survival (SREFS), defined as the time from randomization to the first on-study skeletal-related event or death from any cause. Skeletal-related events include pathologic fracture, spinal cord compression, radiation therapy to a bone lesion, and orthopedic surgery to a bone lesion. Malignant hypercalcemia will be recorded separately as an extended bone event. A fixed-time key analysis is planned at Month 6, with continued follow-up through Month 24.
Secondary endpoints include time to first skeletal-related event; cumulative incidence of skeletal-related events at 6 and 12 months; bone pain outcomes measured by the Brief Pain Inventory; time to pain progression; time to analgesic escalation; quality-of-life outcomes using EORTC QLQ-C30 with optional QLQ-BM22 or QLQ-HCC18; intrahepatic objective response rate and intrahepatic disease control rate at Week 12; intrahepatic progression-free survival, overall progression-free survival, and overall survival; incidence and severity of adverse events; and the frequency and timing of rescue bone-modifying treatment in the control arm.
Baseline imaging must be completed within 14 days before randomization. Tumor imaging is recommended every 8 weeks during the first 6 months and every 12 weeks thereafter until disease progression, death, loss to follow-up, or study end. Pain assessments are performed at baseline, Week 4, Week 8, Month 3, and every 4 weeks through Month 12, then every 8 to 12 weeks during follow-up. The study includes independent blinded endpoint adjudication for skeletal-related events and a Data and Safety Monitoring Board for ongoing safety oversight.
- Conditions
- Hepatocellular Carcinoma (HCC), Bone Metastases
- Being tested
- Denosumab, Sintilimab, Delayed/Rescue Bone-Modifying Strategy
- Keywords
- Denosumab, Bone Metastases, Skeletal-Related Events, Bone Pain, PD-1 Inhibitor
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DenosumabDrug
Denosumab 120 mg administered as a subcutaneous injection every 4 weeks in the upper arm, upper thigh, or abdomen. Pre-existing hypocalcemia must be corrected before treatment initiation. Calcium and vitamin D supplementation should be given as needed to prevent or treat hypocalcemia.
SintilimabDrug
The prespecified PD-1 inhibitor component of the locked uniform systemic therapy backbone used in both study arms. Replace this placeholder with the exact generic name, route, dose, and schedule before final submission.
Delayed/Rescue Bone-Modifying StrategyOther
No routine prophylactic bone-modifying agent is given at baseline. Rescue bone-modifying therapy may be started when predefined triggers occur, including impending or actual pathologic fracture, spinal cord compression or worsening spinal instability, worsening bone pain despite standard management, rapidly progressive bone destruction judged to increase skeletal-related event risk, or malignant hypercalcemia.
| Study group | Role | What they receive |
|---|---|---|
| Early Denosumab Plus Uniform PD-1-Based Systemic Therapy | Experimental | Participants receive early denosumab initiated at baseline together with a locked uniform PD-1-based systemic therapy backbone, plus standard supportive care, analgesic treatment, and clinically necessary local treatment for bone metastases. Receives: Drug: Sintilimab; Other: Delayed/Rescue Bone-Modifying Strategy |
| Delayed/Rescue Bone-Modifying Strategy Plus Uniform PD-1-Based Systemic Therapy | Active comparator | Participants receive the same locked uniform PD-1-based systemic therapy backbone, plus standard supportive care, analgesic treatment, and clinically necessary local treatment for bone metastases, but do not routinely receive prophylactic bone-modifying agents at baseline. Rescue bone-modifying therapy may be initiated only when predefined protocol triggers occur. Receives: Drug: Denosumab; Drug: Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal-Related Event-Free Survival
Skeletal-related event-free survival (SREFS) is defined as the time from randomization to the first on-study skeletal-related event or death from any cause. Skeletal-related events include pathologic fracture, spinal cord compression, radiation therapy to a bone lesion, and orthopedic surgery to a bone lesion. Malignant hypercalcemia is recorded separately as an extended bone event.
Measured: From randomization to the first on-study skeletal-related event or death from any cause, assessed up to 24 months
Secondary outcomes (2)
Time to First Skeletal-Related Event
Time from randomization to the first skeletal-related event.
Measured: From randomization through 24 months
Cumulative Incidence of Skeletal-Related Events
Cumulative incidence of protocol-defined skeletal-related events at 6 and 12 months.
Measured: At 6 months and 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion30 May 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized in a 1:1 ratio to receive either early denosumab plus a locked uniform PD-1-based systemic therapy or the same locked PD-1-based systemic therapy with a delayed/rescue bone-modifying strategy.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Xiaoping, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537972
- Sponsor's protocol ID
- BONE-HCC-010
- Status last verified
- Apr 2026
- First submitted
- 12 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07537972
- Acronym / sponsor ID
- BONE-HCC-010
- Conditions
- Hepatocellular Carcinoma (HCC), Bone Metastases
- Keywords
- Denosumab, Bone Metastases, Skeletal-Related Events, Bone Pain, PD-1 Inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 30 May 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single-center, prospective, randomized, open-label, blinded-endpoint (PROBE) exploratory phase 2 strategy study in patients with hepatocellular carcinoma (HCC) and radiologically or pathologically confirmed bone metastases. A total of 50 participants will be randomized in a 1:1 ratio to either early denosumab plus a locked uniform PD-1-based systemic therapy or the same PD-1-based systemic therapy with a delayed/rescue bone-modifying strategy.
The study is designed to evaluate whether an early denosumab strategy can improve bone-related clinical outcomes in HCC with bone metastases. The key clinical question is not whether denosumab improves short-term intrahepatic radiographic response, but whether early RANKL inhibition can reduce or delay skeletal-related events, delay pain worsening, and improve quality of life when added to a uniform PD-1-based systemic therapy backbone.
The PD-1-based systemic therapy backbone must be locked before enrollment of the first participant and remain consistent throughout the study. Both study arms receive the same locked systemic regimen, standard supportive care, analgesic therapy, and clinically necessary local treatment for bone metastases. The only protocol-defined treatment difference between the two arms is whether denosumab is started at baseline.
Participants randomized to the experimental arm will receive denosumab 120 mg subcutaneously every 4 weeks, with correction of hypocalcemia before treatment initiation and calcium/vitamin D supplementation as indicated. Participants randomized to the control arm will not routinely receive prophylactic bone-modifying agents at baseline. Rescue bone-modifying therapy may be initiated when predefined triggers occur, such as impending or actual pathologic fracture, spinal cord compression or worsening spinal instability, worsening bone pain despite standard management, rapidly progressive bone destruction judged to substantially increase skeletal-related event risk, or malignant hypercalcemia.
The primary endpoint is skeletal-related event-free survival (SREFS), defined as the time from randomization to the first on-study skeletal-related event or death from any cause. Skeletal-related events include pathologic fracture, spinal cord compression, radiation therapy to a bone lesion, and orthopedic surgery to a bone lesion. Malignant hypercalcemia will be recorded separately as an extended bone event. A fixed-time key analysis is planned at Month 6, with continued follow-up through Month 24.
Secondary endpoints include time to first skeletal-related event; cumulative incidence of skeletal-related events at 6 and 12 months; bone pain outcomes measured by the Brief Pain Inventory; time to pain progression; time to analgesic escalation; quality-of-life outcomes using EORTC QLQ-C30 with optional QLQ-BM22 or QLQ-HCC18; intrahepatic objective response rate and intrahepatic disease control rate at Week 12; intrahepatic progression-free survival, overall progression-free survival, and overall survival; incidence and severity of adverse events; and the frequency and timing of rescue bone-modifying treatment in the control arm.
Baseline imaging must be completed within 14 days before randomization. Tumor imaging is recommended every 8 weeks during the first 6 months and every 12 weeks thereafter until disease progression, death, loss to follow-up, or study end. Pain assessments are performed at baseline, Week 4, Week 8, Month 3, and every 4 weeks through Month 12, then every 8 to 12 weeks during follow-up. The study includes independent blinded endpoint adjudication for skeletal-related events and a Data and Safety Monitoring Board for ongoing safety oversight.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized in a 1:1 ratio to receive either early denosumab plus a locked uniform PD-1-based systemic therapy or the same locked PD-1-based systemic therapy with a delayed/rescue bone-modifying strategy.
| Arm | Type | Receives |
|---|---|---|
| Early Denosumab Plus Uniform PD-1-Based Systemic Therapy | Experimental | Drug: Sintilimab, Other: Delayed/Rescue Bone-Modifying StrategyParticipants receive early denosumab initiated at baseline together with a locked uniform PD-1-based systemic therapy backbone, plus standard supportive care, analgesic treatment, and clinically necessary local treatment for bone metastases. |
| Delayed/Rescue Bone-Modifying Strategy Plus Uniform PD-1-Based Systemic Therapy | Active comparator | Drug: Denosumab, Drug: SintilimabParticipants receive the same locked uniform PD-1-based systemic therapy backbone, plus standard supportive care, analgesic treatment, and clinically necessary local treatment for bone metastases, but do not routinely receive prophylactic bone-modifying agents at baseline. Rescue bone-modifying therapy may be initiated only when predefined protocol triggers occur. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DenosumabDenosumab 120 mg administered as a subcutaneous injection every 4 weeks in the upper arm, upper thigh, or abdomen. Pre-existing hypocalcemia must be corrected before treatment initiation. Calcium and vitamin D supplementation should be given as needed to prevent or treat hypocalcemia. | Drug | Delayed/Rescue Bone-Modifying Strategy Plus Uniform PD-1-Based Systemic Therapy |
| SintilimabThe prespecified PD-1 inhibitor component of the locked uniform systemic therapy backbone used in both study arms. Replace this placeholder with the exact generic name, route, dose, and schedule before final submission. | Drug | Delayed/Rescue Bone-Modifying Strategy Plus Uniform PD-1-Based Systemic Therapy, Early Denosumab Plus Uniform PD-1-Based Systemic Therapy |
| Delayed/Rescue Bone-Modifying StrategyNo routine prophylactic bone-modifying agent is given at baseline. Rescue bone-modifying therapy may be started when predefined triggers occur, including impending or actual pathologic fracture, spinal cord compression or worsening spinal instability, worsening bone pain despite standard management, rapidly progressive bone destruction judged to increase skeletal-related event risk, or malignant hypercalcemia. | Other | Early Denosumab Plus Uniform PD-1-Based Systemic Therapy |
Primary outcome
Skeletal-Related Event-Free Survival
Time frame: From randomization to the first on-study skeletal-related event or death from any cause, assessed up to 24 months
Skeletal-related event-free survival (SREFS) is defined as the time from randomization to the first on-study skeletal-related event or death from any cause. Skeletal-related events include pathologic fracture, spinal cord compression, radiation therapy to a bone lesion, and orthopedic surgery to a bone lesion. Malignant hypercalcemia is recorded separately as an extended bone event.
2 secondary outcomes
Time to First Skeletal-Related Event
Time frame: From randomization through 24 months
Cumulative Incidence of Skeletal-Related Events
Time frame: At 6 months and 12 months after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Denosumab, Sintilimab and Delayed/Rescue Bone-Modifying Strategy in people with Hepatocellular Carcinoma (HCC) and Bone Metastases, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhao Huang, M.D (+86 13006378908, huangzhao@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skeletal-Related Event-Free Survival (time frame: From randomization to the first on-study skeletal-related event or death from any cause, assessed up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.