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Real-world study on the efficacy and safety of denosumab as adjuvant therapy for giant cell tumor of bone

Real-world study on the efficacy and safety of denosumab as adjuvant therapy for giant cell tumor of bone

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500108012
Enrollment
Unknown
Registered
2025-08-22
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Giant Cell Tumor of Bone

Interventions

Treatment Group:None

Sponsors

Liaoning Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients must meet all of the following inclusion criteria to be enrolled in this trial: 1. Age: >=18 years old adult or >=16 years old skeletally mature adolescent (defined as at least 1 mature long bone with a weight >=45 kg), regardless of gender; 2. Patients with pathologically confirmed giant cell tumor who have undergone surgery; 3. Measurable evidence of active disease; 4. Eastern Oncology Cooperative Group Performance Status (ECOG PS) <=2; 5. Patients and their guardians are fully informed and sign the informed consent form.

Exclusion criteria

Exclusion criteria: Patients presenting with any of the following conditions are not eligible for enrollment in this study: 1.Pregnant or breastfeeding women; 2.Known hypersensitivity to any of the investigational drugs or to any excipients in different formulations; 3.Presence of hypocalcemia that has not been effectively treated; 4.Acute dental or mandibular disease requiring oral surgery; planned invasive dental procedure; or unresolved dental or oral surgery wounds; 5.Any other condition deemed by the investigator to make the patient unsuitable for participation in the study.

Design outcomes

Primary

MeasureTime frame
Median Relapse-Free Survival (mRFS);

Secondary

MeasureTime frame
6-month and 12-month relapse-free survival (RFS) rates;Change in pain scores (based on BPI-SF);Safety;

Countries

China

Contacts

Public ContactYuming Wang

Liaoning Cancer Hospital

wangyuming@cancerhosp-ln-cmu.com+86 133 0401 3788

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026