Clinical trial · Interventional
Arsenic Trioxide With MAPK Inhibitors and Chemotherapy for Stage 4/M Neuroblastoma
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
NCT06933394CI-TRIAL-00088701recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Arsenic trioxide | Drug | Arsenic Trioxide | ALIAS |
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| MAPK inhibitors | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experiment group
- interventionNames
- Drug: Arsenic trioxide
- Drug: MAPK inhibitors
- Drug: Chemotherapy
Primary outcomes (1)
- measure
- Complete remission rate (CRR)
- timeFrame
- Four weeks after ATO-combined chemotherapy
- description
- Complete remission rate
Secondary outcomes (4)
- measure
- Objective Response Rate (ORR)
- timeFrame
- Four weeks after ATO-combined chemotherapy
- description
- Objective Response Rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Months
- Maximum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.