確診高風險神經母細胞瘤、原發難治性疾病或搶救治療後骨及／或骨髓反應不完全的兒童及成人患者，將接受 naxitamab 及粒細胞-巨噬細胞集落刺激因子（GM-CSF）治療最多 101 週。患者將於首次給藥後隨訪最多五年。 Naxitamab，又稱 hu3F8，是一種靶向 GD2 的人源化單克隆抗體。
適應症：Neuroblastoma
收案條件
納入條件
- Diagnosis of neuroblastoma as defined per International Neuroblastoma Response Criteria
- High-risk neuroblastoma patients with either primary refractory disease or incomplete response to salvage treatment (in both cases including stable disease, minor response and partial response) evaluable in bone and/or bone marrow.
- Life expectancy ≥ 6 months
排除條件
- Any systemic anti-cancer therapy, including chemotherapy or immunotherapy, within 3 weeks before 1st dose of GM-CSF
- Evaluable neuroblastoma outside bone and bone marrow
- Existing major organ dysfunction \> Grade 2, with the exception of hearing loss, hematological status, kidney and liver function
- Active life-threatening infection
收案條件維持 ClinicalTrials.gov 原始英文登錄資料，實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源：ClinicalTrials.gov，每兩週自動更新，最後同步：2026年10月8日。