Giant Cell Tumor of BoneNCT05402865
A Real-world Study on Patients of Unresectable Giant Cell Tumor of Bone
An observational study of Giant Cell Tumor of Bone, run by Shanghai JMT-Bio Inc. at 3 sites in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Giant Cell Tumor of Bone
- What is being tested?
- Denosumab
- Type of treatment
- Injection or infusion
- How many people
- 301 participants
- Where
- 3 sitesChina
- Study dates
- 10 Nov 2021to 18 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Beijing Jishuitan Hospital
Beijing, Beijing Municipality, 100035
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
West China Hospital of Sichuan University
Beijing, Beijing Municipality, 610044
About this study
Official title: A Real-world Study on Patients of Surgically Unsalvageable or Severe Post-surgery Morbidity Associated Giant Cell Tumor of Bone
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
- Being tested
- Denosumab
- Medical subject headings
- Giant Cell Tumor of Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DenosumabDrug
Also called Non-denosumab
Denosumab, subcutaneous injection, specific usage to see the medical records. Non-denosumab, specific usage to see the medical records.
| Study group | Role | What they receive |
|---|---|---|
| Denosumab group | patients who had received denosumab Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks (radiology), or through study completion, an average of 1 year (histopathology)
Secondary outcomes (6)
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
Measured: through study completion, an average of 1 year (radiology and histopathology)
Proportion of patients that is surgically resectable
Measured: through study completion, an average of 1 year
Median duration of tumor response (DOR)
Measured: through study completion, an average of 1 year
Disease control rate (DCR)
Measured: through study completion, an average of 1 year
Time to disease progression (TTP)
Measured: through study completion, an average of 1 year
Types and proportion of key adverse reactions
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start10 Nov 2021
- Primary completion1 Dec 2021
- Study completion18 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Giant Cell Tumor of BoneStudies of the same condition, open and under way.
- More trials run by Shanghai JMT-Bio Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai JMT-Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402865
- Sponsor's protocol ID
- JMT103CN03-1
- Status last verified
- Sep 2021
- First submitted
- 25 May 2022
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41292259
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Study on Patients of Surgically Unsalvageable or Severe Post-surgery Morbidity Associated Giant Cell Tumor of Bone
- ClinicalTrials.gov ID
- NCT05402865
- Acronym / sponsor ID
- JMT103CN03-1
- Conditions
- Giant Cell Tumor of Bone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Shanghai JMT-Bio Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 18 Feb 2022 (actual)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Denosumab group | – | Drug: Denosumabpatients who had received denosumab |
| Non-denosumab group | – | –patients who had received anti-GCTB drug therapy other than denosumab, or who did not receive any anti-GCTB medication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DenosumabAlso: Non-denosumabDenosumab, subcutaneous injection, specific usage to see the medical records. Non-denosumab, specific usage to see the medical records. | Drug | Denosumab group |
Primary outcome
Tumor response rate
Time frame: 12 weeks (radiology), or through study completion, an average of 1 year (histopathology)
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
6 secondary outcomes
Tumor response rate (Key secondary endpoint)
Time frame: through study completion, an average of 1 year (radiology and histopathology)
Proportion of patients that is surgically resectable
Time frame: through study completion, an average of 1 year
Median duration of tumor response (DOR)
Time frame: through study completion, an average of 1 year
Disease control rate (DCR)
Time frame: through study completion, an average of 1 year
Time to disease progression (TTP)
Time frame: through study completion, an average of 1 year
Types and proportion of key adverse reactions
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Derived from this study: PubMed 41292259Xu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Giant Cell Tumor of Bone, run by Shanghai JMT-Bio Inc. at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor response rate (time frame: 12 weeks (radiology), or through study completion, an average of 1 year (histopathology)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05402865, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2022.