Actively Recruiting
Narlumosbartmab Combined With Neoadjuvant Chemotherapy in Bone-derived Malignancies With Osteolytic Lesions and Multinucleated Giant Cells
Led by Peking University People's Hospital · Updated on 2024-03-29
60
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Narlumosbartmab Combined With Neoadjuvant Chemotherapy in Bone-derived Malignancies With Osteolytic Lesions and Multinucleated Giant Cells
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age is more than 8 years old with no gender limitation
- Diagnosed with high-grade bone malignancies of the limb including osteosarcoma, Ewing sarcoma, malignant giant cell tumor, or undifferentiated pleomorphic sarcoma with multinuclear giant cells
- Local tumors and isolated lung lesions must be confirmed by pathology; multiple lung metastases must be resectable
- Newly treated tumors without prior standard therapy and surgery performed at the study center with necrosis rate measured
- ECOG physical status score of 0-1 and expected survival over 6 months
- Adequate blood counts and organ function based on specified lab values
- Negative pregnancy test for sexually active women of childbearing age
- Signed informed consent form or legal representative consent
You will not qualify if you...
- Past or current jaw osteomyelitis or necrosis, unresolved dental or oral surgery, acute dental or jaw diseases needing surgery, or planned invasive dental surgery during study
- Planned intravenous or oral bisphosphonate therapy during study
- Past or current use of anti-RANKL antibodies like disumab
- Unresectable metastatic lesions
- Other malignancies in past 3 years or current treatment with other anti-tumor drugs or specific giant cell tumor therapies
- Central nervous system metastases with symptoms
- Uncontrolled high blood pressure despite treatment
- Significant heart conditions including ischemia, infarction, arrhythmias, low heart function, or recent heart events
- Uncontrolled diabetes, active infections, mental illness, or social issues affecting compliance
- Abnormal blood clotting or current anticoagulant therapy
- History of psychotropic drug abuse or mental disorders
- Conditions affecting oral drug absorption such as swallowing issues or chronic diarrhea
- Active hepatitis B or C or infections requiring antimicrobial treatment
- Participation in other antitumor drug trials within 4 weeks
- Known allergies or intolerances to chemotherapy drugs or their components
- Currently breastfeeding
- Recent vaccination during treatment or within 4 weeks
- Any condition that may harm the participant or prevent study requirements being met
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
Research Team
L
Lu Xie, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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