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New treatment option for Malignant Bone Tumor
Official title Narlumosbartmab Combined With Neoadjuvant Chemotherapy in Bone-derived Malignancies With Osteolytic Lesions and Multinucleated Giant Cells
ClinicalTrials.gov ID: NCT06302465
What this study is testing
What is narlumosbartmab plus doxorubicin、cisplatin、methotrexate、ifosfamide?
narlumosbartmab plus doxorubicin、cisplatin、methotrexate、ifosfamide is an investigational medicine, being studied as a potential treatment for malignant bone tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Malignant tumor of bone is rare with poor prognosis. Surgery is the main treatment for non- metastatic bone tumor.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 and older
You may be able to join if
- 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...
- 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
You likely can't join if
- Past or current jaw osteomyelitis or jaw necrosis; Failure to recover from dental or oral surgery; Acute dental or jaw diseases requiring oral...
- 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...
- Central nervous system metastases with obvious symptoms, such as headache, brain edema, blurred vision, etc.
See the full eligibility criteria
- 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...
- 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.
- 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...
- 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...
- Central nervous system metastases with obvious symptoms, such as headache, brain edema, blurred vision, etc.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.