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

Giant Cell Tumor of Bone Clinical Trial

Official title:

A Real-world Study on Patients of Surgically Unsalvageable or Severe Post-surgery Morbidity Associated Giant Cell Tumor of Bone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05402865
• Other study ID #: JMT103CN03-1
• Status: Completed
• Start date: November 10, 2021
• Est. completion date: February 18, 2022

Study information

• Verified date: September 2021
• Source: Shanghai JMT-Bio Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 301
• Est. completion date: February 18, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 1. Both genders, aged 18 years or above;
• 2. 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;
• 3. 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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Bone Neoplasms
• Giant Cell Tumor of Bone
• Giant Cell Tumors

Intervention

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

Locations

Country	Name	City	State
China	Beijing Jishuitan Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	West China Hospital of Sichuan University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai JMT-Bio Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Tumor response rate (Key secondary endpoint)	Radiographic tumor response (CR/PR evaluated by ICDs or EORTC criteria), or at least 90% reduction of osteoclast like giant cells compared with baseline	through study completion, an average of 1 year (radiology and histopathology)
Secondary	Proportion of patients that is surgically resectable		through study completion, an average of 1 year
Secondary	Median duration of tumor response (DOR)		through study completion, an average of 1 year
Secondary	Disease control rate (DCR)		through study completion, an average of 1 year
Secondary	Time to disease progression (TTP)		through study completion, an average of 1 year
Secondary	Types and proportion of key adverse reactions		through study completion, an average of 1 year