NCT05402865

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

Completed Last updated 2 June 2022

What this trial tests

trial testing Denosumab in Giant Cell Tumor of Bone in 301 participants. Completed in 18 February 2022.

Timeline

10 November 2021

Primary endpoint
1 December 2021

18 February 2022

Quick facts

Lead sponsor	Shanghai JMT-Bio Inc.
Status	Completed
Study type	OBSERVATIONAL
Enrollment	301
Start date	10 November 2021
Primary completion	1 December 2021
Estimated completion	18 February 2022
Sites	3 locations across China

Drugs / interventions tested

• Denosumab (DENOSUMAB) — full drug profile →

Conditions studied

• Giant Cell Tumor of Bone — all drugs for Giant Cell Tumor of Bone →

Sponsor

Shanghai JMT-Bio Inc. — full company profile →

Who can join

18 and older, any sex, with Giant Cell Tumor of Bone. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Antibodies to watch in 2023.
   Kaplon H, Crescioli S, Chenoweth A, Visweswaraiah J, et al · · 2023 · cited 204× · PMID 36472472 · DOI 10.1080/19420862.2022.2153410
2. Antibodies to watch in 2024.
   Crescioli S, Kaplon H, Chenoweth A, Wang L, et al · · 2024 · cited 122× · PMID 38178784 · DOI 10.1080/19420862.2023.2297450
3. Efficacy and safety of JMT103 in patients with unresectable or surgically-challenging giant cell tumor of bone: a multicenter, phase Ib/II study.
   Xu H, Zhou Y, Liang L, Shen J, et al · · 2024 · cited 3× · PMID 39500883 · DOI 10.1038/s41467-024-53686-4
4. 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.
   Xu H, Zhou Y, Wei F, Ding Y, et al · · 2025 · cited 1× · PMID 41292259 · DOI 10.1002/cam4.71340