Spots Global Cancer Trial Database for Narlumosbartmab Combined With Neoadjuvant Chemotherapy in Bone-derived Malignancies With Osteolytic Lesions and Multinucleated Giant Cells

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Trial Identification

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

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

Study ID: NCT06302465

Conditions

Malignant Bone Tumor

Interventions

narlumosbartmab plus doxorubicin、cisplatin、methotrexate、ifosfamide

doxorubicin、cisplatin、methotrexate、ifosfamide

Study Description

Brief 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.

Detailed Description: