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NCT05402865COMPLETEDanonymous

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

Sponsor

Source record

Shanghai JMT-Bio Inc.

Phase

Source record

Not classified

Modality

AI-normalized

monoclonal antibody

Target

AI-normalized

Denosumab

Indication / condition

AI-normalized

Giant Cell Tumor of Bone

Intervention

Source record

Denosumab

Source & freshness

Source record

NCT ID

NCT05402865

Original source

ClinicalTrials.gov

Source last updated

Jun 02, 2022

Ingested at

Jun 18, 2026

Internal sync

Jun 18, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

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NCT ID

NCT05402865

Title

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

Sponsor

Shanghai JMT-Bio Inc.

Status

COMPLETED

Phase

Detailed source ingestion pending

Condition raw

Giant Cell Tumor of Bone

Condition normalized

Giant Cell Tumor of Bone

Modality raw

monoclonal antibody

Modality normalized

monoclonal antibody

Target raw

Denosumab

Target normalized

Denosumab

Interventions

Denosumab

Public preview

Source record

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.

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