Arsenic Trioxide With Chemotherapy for Advanced Neuroblastoma in Children
Tests arsenic trioxide with chemotherapy and MAPK inhibitors in children with advanced neuroblastoma.
Plain-language title generated from the registry record
Registry title: Arsenic Trioxide With MAPK Inhibitors and Chemotherapy for Stage 4/M Neuroblastoma
Key facts
- Where
- Guangzhou, ChinaSee the site
- Phase
- Phase 2
Where in China
- Sun Yat-sen Memorial HospitalGuangzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Trial code
- NCT06933394
- Record updated
- 18 April 2025
- Original description
This prospective, single-arm, multi-center clinical trial aims to explore and evaluate the efficacy and safety of the combination therapy involving arsenic trioxide, MAPK inhibitors, and chemotherapy for stage 4/M neuroblastoma.Read full original descriptionShow less
A Prospective, Single-arm, Multicentre Phase II Clinical Study of Arsenic Trioxide in Combination With Chemotherapy and MAPK Pathway Inhibitors for Stage 4/M Neuroblastoma
This prospective, single-arm, multi-center clinical trial aims to explore and evaluate the efficacy and safety of the combination therapy involving arsenic trioxide, MAPK inhibitors, and chemotherapy for stage 4/M neuroblastoma.
Inclusion: Patients with a pathological diagnosis of neuroblastoma; Preoperative staging as INRG M stage or postoperative staging as INSS stage 4 (regardless of risk classification); Age ≥18 months and ≤18 years; Informed consent obtained from the legal guardian, and signed informed consent form.
Exclusion: Patients with a history of other tumors who have received chemotherapy and abdominal radiation therapy; Severe progressive or persistent heart failure: NYHA heart function class III or IV, or left ventricular ejection fraction (LVEF) < 50%; Severe progressive or persistent renal failure: glomerular filtration rate (GFR) < 30 ml/(min·1.73 m²) or serum creatinine > 5 mg/dL (442 μmol/L); Severe liver dysfunction: aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≥ 5× upper limit of normal (ULN), or serum total bilirubin ≥ 3× ULN.