Pediatric neuroblastoma
Conditions
Interventions
treatment group:Radiotherapy +naxitamab + GM-CSF
Sponsors
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
1 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Age 1 to 18 years. 2. Diagnosis of high-risk neuroblastoma according to the International Neuroblastoma Risk Group (INRG) criteria. 3. Primary refractory disease is defined as failure to achieve complete remission or very good partial remission after standard induction therapy (4-6 cycles of chemotherapy plus surgery), including stable disease (SD), minor response (MR), and partial remission (PR). 4. Measurable active lesions are defined as: <= 3 lesions with a diameter of <= 3 cm in bone/bone marrow and/or 1 lesion with a diameter of <= 1.5 cm in soft tissue, as demonstrated by DOPA PET/CT examination. Active lesions are identified as anatomical sites with positive DOPA uptake; local MRI confirmation may be required. 5. Female patients of childbearing age must have a negative pregnancy test. Male and female patients of childbearing age must agree to use effective contraceptive measures during the treatment period and for 6 months after the treatment is discontinued. 6. Patients deemed by the investigator's clinical judgment to be suitable for treatment according to this study protocol. 7. A written informed consent must be signed by the legal guardian(s) of the pediatric patient. When the pediatric patient is capable of making the decision to participate in the clinical trial, both the pediatric patient and the legal guardian(s) must provide their consent on the form.
Exclusion criteria
Exclusion criteria: 1. Investigator-assessed life expectancy of less than 3 months. 2. Lansky Play Performance Scale (=16 years) score 50 mmHg, FEV1 5 × upper normal limit (UNL) b. Bilirubin > 1.5 × UNL 11. Moderate or severe renal insufficiency, defined as estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m². 12. Inability to comply with the safety monitoring requirements of this study or poor compliance anticipated, as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of achieving complete remission or very good partial remission (CR + VGPR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Three-year progression-free survival rate;3-year overall survival rate;Objective Response Rate, ORR;Duration of relief; | — |
Countries
China
Contacts
Public ContactMawei Jiang
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed