A Real-world Study on Patients of Unresectable Giant Cell Tumor of Bone

NCT05402865 | Completed

• 1 other identifier: JMT103CN03-1
• Study Type: observational
• Target: 301
• Locations: 1 country
• Sites: 3

Brief Summary

This is a retrospective observational real-world study, which evaluates the efficacy and safety of denosumab and non-denosumab therapies in the treatment of Chinese populations of surgically unsalvageable or severe post-surgery morbidity associated giant cell tumor of bone (GCTB), collectively referred to as unresectable GCTB, during 2013-2021 in three medical centers, serving as the external control for a single arm phase Ib/II trial on JMT103 treatment of GCTB. 301 patients were enrolled and divided into 2 groups according to their actual previous exposures. Group 1 (n=135) was denosumab group. Group 2 (n=166) included two types of exposures other than denosumab: other anti-GCTB drug therapies, or no therapy on GCTB patients. The dosage, route, frequency and other administration methods was collected according to the actual previous treatment records. The primary outcome measure was the tumor response rate \[radiographic tumor response (CR/PR evaluated by ICDs or EORTC criteria) within 12 weeks, or at least 90% reduction of osteoclast like giant cells compared with baseline\]. The key secondary endpoint was the tumor response rate \[radiographic tumor response (CR/PR evaluated by ICDS or EORTC criteria), or at least 90% reduction of osteoclast like giant cells compared with baseline\]. Other secondary Outcome Measures include: proportion of patients whose tumors was surgically resectable; median duration of tumor response (DOR), disease control rate (DCR), and time to disease progression (TTP); and types and proportion of key adverse reactions.

Conditions

Giant Cell Tumor of Bone

Outcome Measures

Primary Outcomes (1)

• Tumor response rate

  Radiographic tumor response (CR/PR evaluated by ICDs or EORTC criteria) within 12 weeks, or at least 90% reduction of osteoclast like giant cells compared with baseline

  12 weeks (radiology), or through study completion, an average of 1 year (histopathology)

Secondary Outcomes (6)

• Tumor response rate (Key secondary endpoint)

  through study completion, an average of 1 year (radiology and histopathology)

• Proportion of patients that is surgically resectable

  through study completion, an average of 1 year

• Median duration of tumor response (DOR)

  through study completion, an average of 1 year

• Disease control rate (DCR)

  through study completion, an average of 1 year

• Time to disease progression (TTP)

  through study completion, an average of 1 year

Study Arms (2)

Denosumab group

patients who had received denosumab

Drug: Denosumab

Non-denosumab group

patients who had received anti-GCTB drug therapy other than denosumab, or who did not receive any anti-GCTB medication

Interventions

Denosumab DRUG

Denosumab, subcutaneous injection, specific usage to see the medical records. Non-denosumab, specific usage to see the medical records.

Also known as: Non-denosumab

Denosumab group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Chinese

You may qualify if:

• \. Both genders, aged 18 years or above;
• \. Patients pathologically diagnosed of giant cell tumor of bone (GCTB), and are surgically unsalvageable, or salvageable but surgery was associated with severe morbidity based on physician's judgement;
• \. For patients received denosumab or other anti-GCTB medications, one of the two is required: imaging data (including X-ray, CT, MRI or PET-CT) prior to and at least once followed to administration, or pathological data on surgically resected GCTB; for patients with no medication, imaging data or pathological data on surgically resected GCTB is required.

You may not qualify if:

• \. No access to definite treatment information;
• \. Bone metabolic diseases diagnosed before treatment: hypo-/ hyperparathyroidism, hypo-/hyperthyroidism, hypopituitarism, hyperprolactinemia, Cushing syndrome, acromegaly, Paget disease, etc;
• \. Complication of malignant tumor receiving anti-tumor therapy.

Sponsors & Collaborators

• Shanghai JMT-Bio Inc.: lead

Study Sites (3)

Beijing Jishuitan Hospital

Beijing, Beijing Municipality, 100035, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

West China Hospital of Sichuan University

Beijing, Beijing Municipality, 610044, China

Location

Related Publications (1)

• Xu H, Zhou Y, Wei F, Ding Y, Shan H, Yang Y, Liu W, Jin T, Luo Y, Tang F, Lu M, He X, Zhang W, Yang S, Zhang L, Wang J, Li H, Tu C, Niu X. JMT103 versus Non-Denosumab or Denosumab Treatment in Chinese Patients with Unresectable or Surgically Challenging Giant Cell Tumor of Bone: A Propensity Score-Matched Comparison. Cancer Med. 2025 Nov;14(22):e71340. doi: 10.1002/cam4.71340.

  PMID: 41292259 DERIVED

MeSH Terms

Conditions

Giant Cell Tumor of Bone

Interventions

Denosumab

Condition Hierarchy (Ancestors)

Giant Cell Tumors; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Bone Tissue

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: June 2, 2022
• Study Start: November 10, 2021
• Primary Completion: December 1, 2021
• Study Completion: February 18, 2022
• Last Updated: June 2, 2022

Record last verified: 2021-09

Locations

CN (3)