Arsenic Trioxide With MAPK Inhibitors and Chemotherapy for Stage 4/M Neuroblastoma

Summary

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.

Eligibility

Inclusion Criteria:

1. Patients with a pathological diagnosis of neuroblastoma.
2. Preoperative staging as INRG M stage or postoperative staging as INSS stage 4 (regardless of risk classification).
3. Age ≥18 months and ≤18 years.
4. Informed consent obtained from the legal guardian, and signed informed consent form.

Exclusion Criteria:

1. Patients with a history of other tumors who have received chemotherapy and abdominal radiation therapy.
2. Severe progressive or persistent heart failure: NYHA heart function class III or IV, or left ventricular ejection fraction (LVEF) \< 50%.
3. 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).
4. Severe liver dysfunction: aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≥ 5× upper limit of normal (ULN), or serum total bilirubin ≥ 3× ULN.

Conditions2

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