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Trial Title:
Narlumosbartmab Combined With Neoadjuvant Chemotherapy in Bone-derived Malignancies With Osteolytic Lesions and Multinucleated Giant Cells
NCT ID:
NCT06302465
Condition:
Malignant Bone Tumor
Conditions: Official terms:
Bone Neoplasms
Cisplatin
Doxorubicin
Liposomal doxorubicin
Methotrexate
Ifosfamide
Isophosphamide mustard
Conditions: Keywords:
Narlumosbartmab
Malignant bone tumor
Multinucleated giant cell
Osteoclast-like giant cell
Osteolytic
RANKL inhibitor
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
narlumosbartmab plus doxorubicin、cisplatin、methotrexate、ifosfamide
Description:
Narlumosbartmab is combined with neoadjuvant chemotherapy at 120mg i.h. in day 1, 8, 15,
28 and every 28 days after that.
Arm group label:
narlumosbartmab plus neoadjuvant chemotherapy
Intervention type:
Drug
Intervention name:
doxorubicin、cisplatin、methotrexate、ifosfamide
Description:
doxorubicin(37.5mg/m^2/d)、cisplatin(120mg/m^2/d)、methotrexate(8-12g/m^2/d)、ifosfamide(2.4
g/m^2/d)
Arm group label:
neoadjuvant chemotherapy
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. 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age is more than 8 years old and no gender limitation.
2. 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.
3. 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.
4. The ECOG physical status score is 0-1, and the expected survival period is more than
6 months.
5. 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
6. Pregnancy test (urine beta-HCG) negative (for sexually active women of childbearing
age).
7. 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.
Exclusion Criteria:
1. 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.
2. Any planned intravenous or oral bisphosphonate therapy during the study period.
3. Past or current use of anti-nuclear factor κB activator ligand (RANKL) antibodies,
such as disumab.
4. Metastatic lesions determined by doctors to be unresectable.
5. 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).
6. Central nervous system metastases with obvious symptoms, such as headache, brain
edema, blurred vision, etc.
7. Uncontrolled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood
pressure ≥90 mmHg, despite best medical treatment).
8. 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).
9. 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.
10. 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.
11. 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.
12. Patients with a history of psychotropic drug abuse and are unable to quit or have
mental disorders.
13. With significant factors affecting the absorption of oral drugs, such as inability
to swallow, chronic diarrhea and intestinal obstruction.
14. Patients with active viral hepatitis B or hepatitis C, or those with active
infections requiring antimicrobial treatment (e.g. antibiotics, antiviral drugs,
antifungal drugs).
15. Have participated in clinical trials of other antitumor drugs within 4 weeks.
16. Known allergic reactions, hypersensitivities, or intolerances to chemotherapy agents
or their excipients.
17. During lactation.
18. Patients received vaccination during the course of treatment, or within 4 weeks of
vaccination.
19. 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.
Gender:
All
Minimum age:
8 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University People's Hospital
Address:
City:
Beijing
Zip:
100044
Country:
China
Status:
Recruiting
Contact:
Last name:
Lu Xie, M.D.
Phone:
+8613401044719
Email:
xie.lu@hotmail.com
Start date:
May 1, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Peking University People's Hospital
Agency class:
Other
Source:
Peking University People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06302465