To explore the efficacy of adding anti-GD2 immunotherapy (Naxitamab) at the stage of induction chemotherapy for newly diagnosed high risk neuroblastoma patients. To investigate wether anding Naxitamab in the induction phase will improve the response rate at the end of induction therapy and further improve the overall survival rate.
Study Type
OBSERVATIONAL
Enrollment
64
Addition of anti-GD2 immunotherapy (Naxitamab) at the stage of induction chemotherapy
Guangzhou Women And Children's Medical Center
Guanzhou, Guangdong, China
RECRUITINGThe number of the patients of VGPR or CR at the end of induction therapy
Measured by cross-sectional computed tomography (CT) or magnetic resonance imaging (MRI) imaging and/or by methyl iodobenzylguanidine (MIBG) or positron emission tomography (PET) scans and bone marrow (BM) responses, evaluated according to the 1993 International Neuroblastoma Response Criteria (INRC), and compared with relevant historical control groups.
Time frame: 5 years
Objective Response Rate (ORR)
According to the International Neuroblastoma Response Criteria (INRC) of 1993 and 2017, the proportion of complete or partial responses was calculated in newly diagnosed high-risk group patients with neuroblastoma who received standard induction therapy. The disease status was evaluated by CT or MRI and/or MIBG or PET scans and bone marrow aspiration. After two courses of treatment, the proportion of complete or partial responses was calculated in newly diagnosed high-risk group patients with neuroblastoma who received standard induction therapy after two courses of treatment were completed.
Time frame: 5 years
The number of days a patient survives
The overall survival (OS) of patients receiving standard-induced chemotherapy and GD2 antibody combination therapy.
Time frame: 3 years after the last patient was enrolled
The number of days the patient survive without relapse or progression
The event-free survival (EFS) of patients receiving standard-induced chemotherapy and GD2 antibody combination therapy.
Time frame: 3 years after the last patient was enrolled
The objective response rate (ORR) after 6 cycles of treatment.
The objective response rate (ORR) after 6 cycles of treatment.
Time frame: 5 years
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The number of patients with adverse events related to treatment
The number of patients with adverse events related to treatment
Time frame: 5 years