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RECRUITING
NCT06302465
NA

Narlumosbartmab Combined With Neoadjuvant Chemotherapy in Bone-derived Malignancies With Osteolytic Lesions and Multinucleated Giant Cells

Sponsor: Peking University People's Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

8 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-05-01

Completion Date

2026-12-31

Last Updated

2024-03-29

Healthy Volunteers

No

Interventions

DRUG

narlumosbartmab plus doxorubicin、cisplatin、methotrexate、ifosfamide

Narlumosbartmab is combined with neoadjuvant chemotherapy at 120mg i.h. in day 1, 8, 15, 28 and every 28 days after that.

DRUG

doxorubicin、cisplatin、methotrexate、ifosfamide

doxorubicin(37.5mg/m\^2/d)、cisplatin(120mg/m\^2/d)、methotrexate(8-12g/m\^2/d)、ifosfamide(2.4g/m\^2/d)

Locations (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China