Malignant Bone TumorNCT06302465
Narlumosbartmab Combined With Neoadjuvant Chemotherapy in Bone-derived Malignancies With Osteolytic Lesions and Multinucleated Giant Cells
A study testing narlumosbartmab plus doxorubicin、cisplatin、methotrexate、ifosfamide and doxorubicin、cisplatin、methotrexate、ifosfamide in people with Malignant Bone Tumor, run by Peking University People's Hospital at 1 site in China.
Trial summary
Malignant tumor of bone is rare with poor prognosis. Surgery is the main treatment for non- metastatic bone tumor. Although neoadjuvant chemotherapy for non-metastatic bone tumor cannot improve survival rate based on adjuvant chemotherapy, it can reduce and clarify tumor boundary. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Malignant Bone Tumor
- What is being tested?
- narlumosbartmab plus doxorubicin、cisplatin、methotrexate、ifosfamide and doxorubicin、cisplatin、methotrexate、ifosfamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age is more than 8 years old and no gender limitation.
- Histopathologically confirmed high-grade bone-origin malignancies of the limb with the following subtypes: high-grade osteosarcoma, Ewing sarcoma or Ewing sarcoma, malignant giant cell tumor, and undifferentiated pleomorphic sarcoma of bone (the pathological descriptions of the above disease types must include multinuclear giant cell components). Local tumors and isolated lung lesions must be confirmed by pathological diagnosis and multiple lung metastases must be determined by an experienced thoracic surgeon to be resectable.
- For newly treated tumors that have not been treated with standard therapy and surgery is performed at our center and the necrosis rate is measured.
- The ECOG physical status score is 0-1, and the expected survival period is more than 6 months.
- Hb≥ 120g/L，ANC≥1.5×109/L，PLT≥ 100×109/L Cr≤ 1.5×ULN，BUN≤ 2.5×ULN, TB≤ 1.5×ULN, AST and ALT≤ 2.5×ULN, ALB≥ 30 g/L INR）≤1.5，PT and APTT≤1.5×ULN
- Pregnancy test (urine beta-HCG) negative (for sexually active women of childbearing age).
- Sign an informed consent form (or legal representative sign) to demonstrate that patients understand the purpose of the study and the procedures required by the study and are willing to participate in the study.
Who cannot join
- Past or current jaw osteomyelitis or jaw necrosis; Failure to recover from dental or oral surgery; Acute dental or jaw diseases requiring oral surgery; Those who planned to undergo invasive dental surgery during the study period.
- Any planned intravenous or oral bisphosphonate therapy during the study period.
- Past or current use of anti-nuclear factor κB activator ligand (RANKL) antibodies, such as disumab.
- Metastatic lesions determined by doctors to be unresectable.
- Have had other malignancies in the past 3 years, are currently being treated with other anti-tumor drugs, or are currently receiving other specific treatments for giant cell tumors of bone (such as radiation, chemotherapy, or embolization).
- Central nervous system metastases with obvious symptoms, such as headache, brain edema, blurred vision, etc.
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- Uncontrolled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, despite best medical treatment).
- Patients with grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥450 ms for men and ≥470 ms for women).
- Patients with grade Ⅲ to Ⅳ cardiac insufficiency according to NYHA criteria, or with left ventricular ejection fraction (LVEF) < 50% indicated by heart color ultrasound, or had myocardial infarction within 6 months before enrollment, or with grade II or above heart failure according to NYHA criteria, uncontrolled angina, uncontrolled severe ventricular arrhythmia, and clinically significant pericardial disease, or electrocardiogram indicates acute ischemia or abnormal active conduction system.
- Uncontrolled co-morbidities include, but are not limited to poorly controlled diabetes, persistent active infections, or mental illness or social conditions that may affect participants' compliance with the study.
- Abnormal coagulation function (INR >1.5 or prothrombin time (PT) > ULN+4 seconds or APTT >1.5 ULN), have a tendency to bleed or are receiving thrombolytic or anticoagulant therapy.
- Patients with a history of psychotropic drug abuse and are unable to quit or have mental disorders.
- With significant factors affecting the absorption of oral drugs, such as inability to swallow, chronic diarrhea and intestinal obstruction.
- Patients with active viral hepatitis B or hepatitis C, or those with active infections requiring antimicrobial treatment (e.g. antibiotics, antiviral drugs, antifungal drugs).
- Have participated in clinical trials of other antitumor drugs within 4 weeks.
- Known allergic reactions, hypersensitivities, or intolerances to chemotherapy agents or their excipients.
- During lactation.
- Patients received vaccination during the course of treatment, or within 4 weeks of vaccination.
- Any condition which, in the opinion of the investigator, is likely to harm the subject or cause the subject to be unable to meet or perform the study requirements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Lu Xie, M.D., +8613401044719, xie.lu@hotmail.com
About this study
Official title: Comparison of Narlumosbartmab Combined With Neoadjuvant Chemotherapy and Neoadjuvant Chemotherapy Alone in Bone-derived Malignancies With Osteolytic Lesions and Multinucleated Giant Cells in Local Recurrence Rates: a Prospective, Randomized, Controlled, Two-arm, Open, Single-center Clinical Trial
Malignant tumor of bone is rare with poor prognosis. Surgery is the main treatment for non- metastatic bone tumor. Although neoadjuvant chemotherapy for non-metastatic bone tumor cannot improve survival rate based on adjuvant chemotherapy, it can reduce and clarify tumor boundary. Control of local recurrence rate is the core objective of oncotherapy. Surgery way and boundary have a significant effect on prognosis of non- metastatic bone tumor. Narlumosbartmab, a RANKL inhibitor, can make tumor boundary clear and reduce surgical difficulty by inhibiting osteoclast. This is a prospective, randomized, controlled, two-arm, open, single-center clinical trial to compare the efficacy and safety of narlumosbartmab combined with neoadjuvant chemotherapy and neoadjuvant chemotherapy alone in bone-derived malignancies with bone lytic lesions and multinucleated giant cells. Investigators mainly observe the local recurrence rate to evaluate the survival benefit for patients with poor prognosis.
- Conditions
- Malignant Bone Tumor
- Being tested
- narlumosbartmab plus doxorubicin、cisplatin、methotrexate、ifosfamide, doxorubicin、cisplatin、methotrexate、ifosfamide
- Keywords
- Narlumosbartmab, Malignant bone tumor, Multinucleated giant cell, Osteoclast-like giant cell, Osteolytic, RANKL inhibitor
- Medical subject headings
- Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
narlumosbartmab plus doxorubicin、cisplatin、methotrexate、ifosfamideDrug
Narlumosbartmab is combined with neoadjuvant chemotherapy at 120mg i.h. in day 1, 8, 15, 28 and every 28 days after that.
doxorubicin、cisplatin、methotrexate、ifosfamideDrug
doxorubicin(37.5mg/m^2/d)、cisplatin(120mg/m^2/d)、methotrexate(8-12g/m^2/d)、ifosfamide(2.4g/m^2/d)
| Study group | Role | What they receive |
|---|---|---|
| neoadjuvant chemotherapy | Active comparator | Not described Receives: Drug: doxorubicin、cisplatin、methotrexate、ifosfamide |
| narlumosbartmab plus neoadjuvant chemotherapy | Experimental | Not described Receives: Drug: narlumosbartmab plus doxorubicin、cisplatin、methotrexate、ifosfamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
local recurrence rate
Measured: 2 years
Secondary outcomes (4)
tumor necrosis rate
Measured: 12 weeks
R0 removal rate
R0 remove mains the pathological margin is negative.
Measured: 12 weeks
Event-free survival
Measured: 2 years
Overall survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start1 May 2024 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Bone TumorStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xie Lu, Peking University People's Hospital
- Investigators
- Lu Xie, M.D., Principal investigator, Musculoskeletal Tumor Center of Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302465
- Sponsor's protocol ID
- PKUPH-sarcoma 18
- Status last verified
- Mar 2024
- First submitted
- 25 Feb 2024
- Last updated
- 29 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Narlumosbartmab Combined With Neoadjuvant Chemotherapy and Neoadjuvant Chemotherapy Alone in Bone-derived Malignancies With Osteolytic Lesions and Multinucleated Giant Cells in Local Recurrence Rates: a Prospective, Randomized, Controlled, Two-arm, Open, Single-center Clinical Trial
- ClinicalTrials.gov ID
- NCT06302465
- Acronym / sponsor ID
- PKUPH-sarcoma 18
- Conditions
- Malignant Bone Tumor
- Keywords
- Narlumosbartmab, Malignant bone tumor, Multinucleated giant cell, Osteoclast-like giant cell, Osteolytic, RANKL inhibitor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Mar 2024 (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.
Malignant tumor of bone is rare with poor prognosis. Surgery is the main treatment for non- metastatic bone tumor. Although neoadjuvant chemotherapy for non-metastatic bone tumor cannot improve survival rate based on adjuvant chemotherapy, it can reduce and clarify tumor boundary. Control of local recurrence rate is the core objective of oncotherapy. Surgery way and boundary have a significant effect on prognosis of non- metastatic bone tumor. Narlumosbartmab, a RANKL inhibitor, can make tumor boundary clear and reduce surgical difficulty by inhibiting osteoclast. This is a prospective, randomized, controlled, two-arm, open, single-center clinical trial to compare the efficacy and safety of narlumosbartmab combined with neoadjuvant chemotherapy and neoadjuvant chemotherapy alone in bone-derived malignancies with bone lytic lesions and multinucleated giant cells. Investigators mainly observe the local recurrence rate to evaluate the survival benefit for patients with poor prognosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neoadjuvant chemotherapy | Active comparator | Drug: doxorubicin、cisplatin、methotrexate、ifosfamide |
| narlumosbartmab plus neoadjuvant chemotherapy | Experimental | Drug: narlumosbartmab plus doxorubicin、cisplatin、methotrexate、ifosfamide |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Age is more than 8 years old and no gender limitation.
- Histopathologically confirmed high-grade bone-origin malignancies of the limb with the following subtypes: high-grade osteosarcoma, Ewing sarcoma or Ewing sarcoma, malignant giant cell tumor, and undifferentiated pleomorphic sarcoma of bone (the pathological descriptions of the above disease types must include multinuclear giant cell components). Local tumors and isolated lung lesions must be confirmed by pathological diagnosis and multiple lung metastases must be determined by an experienced thoracic surgeon to be resectable.
- For newly treated tumors that have not been treated with standard therapy and surgery is performed at our center and the necrosis rate is measured.
- The ECOG physical status score is 0-1, and the expected survival period is more than 6 months.
- Hb≥ 120g/L，ANC≥1.5×109/L，PLT≥ 100×109/L Cr≤ 1.5×ULN，BUN≤ 2.5×ULN, TB≤ 1.5×ULN, AST and ALT≤ 2.5×ULN, ALB≥ 30 g/L INR）≤1.5，PT and APTT≤1.5×ULN
Key exclusion criteria (19 listed)
- Past or current jaw osteomyelitis or jaw necrosis; Failure to recover from dental or oral surgery; Acute dental or jaw diseases requiring oral surgery; Those who planned to undergo invasive dental surgery during the study period.
- Any planned intravenous or oral bisphosphonate therapy during the study period.
- Past or current use of anti-nuclear factor κB activator ligand (RANKL) antibodies, such as disumab.
- Metastatic lesions determined by doctors to be unresectable.
- Have had other malignancies in the past 3 years, are currently being treated with other anti-tumor drugs, or are currently receiving other specific treatments for giant cell tumors of bone (such as radiation, chemotherapy, or embolization).
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 |
|---|---|---|
| narlumosbartmab plus doxorubicin、cisplatin、methotrexate、ifosfamideNarlumosbartmab is combined with neoadjuvant chemotherapy at 120mg i.h. in day 1, 8, 15, 28 and every 28 days after that. | Drug | narlumosbartmab plus neoadjuvant chemotherapy |
| doxorubicin、cisplatin、methotrexate、ifosfamidedoxorubicin(37.5mg/m^2/d)、cisplatin(120mg/m^2/d)、methotrexate(8-12g/m^2/d)、ifosfamide(2.4g/m^2/d) | Drug | neoadjuvant chemotherapy |
Primary outcome
local recurrence rate
Time frame: 2 years
4 secondary outcomes
tumor necrosis rate
Time frame: 12 weeks
R0 removal rate
Time frame: 12 weeks
Event-free survival
Time frame: 2 years
Overall survival
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
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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.
Lu Xie, M.D. principal investigator
Musculoskeletal Tumor Center of Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing narlumosbartmab plus doxorubicin、cisplatin、methotrexate、ifosfamide and doxorubicin、cisplatin、methotrexate、ifosfamide in people with Malignant Bone Tumor, run by Peking University People's Hospital at 1 site 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 7 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lu Xie, M.D. (13401044719, xielu@pkuph.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
local recurrence rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Mar 2024.