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Denosumab Strategy for Liver Cancer With Bone Metastases

NCT07537972 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-04-17

No results posted yet for this study

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. 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.

Conditions

Interventions

DRUG

Denosumab

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.

DRUG

Sintilimab

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.

OTHER

Delayed/Rescue Bone-Modifying Strategy

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.

Sponsors & Collaborators

  • Tongji Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2029-05-30
Completion
2029-06-30

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07537972 on ClinicalTrials.gov