Giant Cell Tumor of Bone
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| Median Relapse-Free Survival (mRFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| 6-month and 12-month relapse-free survival (RFS) rates;Change in pain scores (based on BPI-SF);Safety; | — |
Countries
China
Contacts
Liaoning Cancer Hospital