Status:
RECRUITING
Arsenic Trioxide With MAPK Inhibitors and Chemotherapy for Stage 4/M Neuroblastoma
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions:
Neuroblastoma
Eligibility:
All Genders
18-18 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
Neuroblastoma (NB) is the most common extracranial solid tumor in children. Since 2018, we have led a prospective, nationwide multicenter collaborative clinical study on arsenic trioxide(ATO) combined...
Eligibility Criteria
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.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2031
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT06933394
Start Date
May 1 2025
End Date
May 1 2031
Last Update
April 18 2025
Active Locations (1)
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1
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China, 510120