Clinical trial · Interventional
Phase II Study of Combined Chemotherapy With Arsenic Trioxide in Stage 4/M Neuroblastoma
Clinical Research on Efficacy and Safety of Combined Chemotherapy With Arsenic Trioxide in Stage 4/M Neuroblastoma：A Prospective，Single-arm, Open-label, Multi-center Study
NCT03503864CI-TRIAL-00089979active not recruitingPhase 2Results postedClinicalTrials.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 clinical trial aims to explore and evaluate the efficacy and safety of combined chemotherapy with arsenic trioxide 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Arsenic Trioxide | Drug | Arsenic Trioxide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ATO-combined chemotherapy
- description
- Patients receive combined induction chemotherapy with arsenic trioxide.
- interventionNames
- Drug: Arsenic Trioxide
Primary outcomes (1)
- measure
- Objective Response Rate
- timeFrame
- Four weeks after ATO-combined induction chemotherapy
- description
- The percentage of patients who had complete remission（CR）or partial remission（PR）after induction chemotherapy combined ATO. Per Response Evaluation Criteria In Solid Tumors Criteria (WHO criteria) for target lesions and assessed by MRI or CT: CR: All lesions completely disappear, maintained for at least 4 weeks. PR: Estimated tumor size reduction by more than 50%, maintained for at least 4 weeks.
Secondary outcomes (3)
- measure
- Overall Survival Rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 14 Years
Show eligibility criteria text
Inclusion Criteria: 1. Untreated Stage 4/M neuroblastoma patients according to the International Neuroblastoma Staging System（INSS) or the International Neuroblastoma Risk Group (INRG) staging system; 2. Patients not more than 14 years old; 3. There are measurable lesions; 4. Guardians agreed and signed informed consent. Exclusion Criteria: 1. Patients who had suffered from other tumors and received chemotherapy or abdominal radiotherapy. 2. Patients with one or more critical organs failure such as heart, brain, kidney failure.
References
Publications (0)
Data not yet available
No reference posted for this study.