Clinical trial · Interventional
Arsenic Trioxide Combined With Chemotherapy for the Treatment of p53-mutated Pediatric Cancer
Clinical Research on Efficacy and Safety of Arsenic Trioxide Combined With Chemotherapy in p53-mutated Pediatric Cancer Patients：A Prospective，Single-arm, Multi-center Study
NCT06088030CI-TRIAL-00072695recruitingPhase 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 arsenic trioxide combined with chemotherapy for pediatric cancer with p53 mutation.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Li-Fraumeni Syndrome | — | UNRESOLVED | — |
| p53 Mutations | — | UNRESOLVED | — |
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 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
- Arsenic trioxide combined chemotherapy
- description
- Patients with p53-mutated pediatric cancer should initially undergo the corresponding first-line chemotherapy regimen. If the patient is evaluated as PD/SD, arsenic trioxide (ATO) will be administered in conjunction with previous conventional chemotherapy on the third day of each treatment cycle.
- interventionNames
- Drug: Arsenic trioxide
Primary outcomes (1)
- measure
- Objective response rate
- timeFrame
- Four weeks after ATO-combined chemotherapy
- description
- Objective response rate
Secondary outcomes (3)
- measure
- Progression Free Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Pathological diagnosis basis of malignant tumor； 2. Patients not more than 18 years old; 3. Patient has either germline or somatic p53 mutations, which was shown to be partially/completely restored to function by ATO in in vitro experiments (http://www.rescuep53.net); 4. There are measurable lesions; 5. Guardians agreed and signed informed consent. Exclusion Criteria: 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.