eligibility_summary
Eligible: consented patients 18 months-18 years with confirmed neuroblastoma/ganglioneuroblastoma, high-risk per GPOH-NB2004 (INSS stage 4), PS >=70%, life expectancy >=12 wks, no neuropathy, adequate liver (ALT/AST <5x ULN), renal (GFR >60 ml/min/1.73 m2), coagulation (PTI 70-120%, APTT <36 s), cardiac (LVEF >=55%), and respiratory (SpO2 >94%, normal CXR). Exclude: low/intermediate risk (INSS 1-3, 4s no MYCN amp, stage 4 <18 mo) and high-risk 1-3/4s with MYCN amp, drug intolerance, or pregnancy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Intervention: Single-arm induction chemoimmunotherapy combining N5/N6 chemotherapy with dinutuximab beta (ch14.18/CHO, anti‑GD2 IgG1 monoclonal antibody) plus G‑CSF. Drug types/mechanisms: cisplatin (platinum DNA crosslinker), etoposide (topoisomerase II inhibitor), vincristine (vinca alkaloid, microtubule inhibitor), dacarbazine (alkylating/methylating prodrug), ifosfamide (alkylating agent), doxorubicin (anthracycline, intercalation/topo II/ROS). Dinutuximab beta binds GD2 to induce NK cell/macrophage Fc‑mediated ADCC and complement‑dependent cytotoxicity. Cells/pathways targeted: GD2+ neuroblastoma/ganglioneuroblastoma cells, DNA damage/replication and mitotic spindle pathways, G‑CSF acts on myeloid progenitors (CSF3R) to restore neutrophils.