NCT06933394 Arsenic Trioxide With MAPK Inhibitors and Chemotherapy for Stage 4/M Neuroblastoma
| NCT ID | NCT06933394 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
| Condition | Neuroblastoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 92 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2031-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 92 participants in total. It began in 2025-05-01 with a primary completion date of 2031-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 for stage 4/M neuroblastoma.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06933394 clinical trial?
This trial is open to participants of all sexes, aged 18 Months or older, up to 18 Years, studying Neuroblastoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06933394 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06933394 currently recruiting?
Yes, NCT06933394 is actively recruiting participants. Contact the research team at drliyang@126.com for enrollment information.
Where is the NCT06933394 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06933394 clinical trial?
NCT06933394 is sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. The trial plans to enroll 92 participants.