NCT06088030 Arsenic Trioxide Combined With Chemotherapy for the Treatment of p53-mutated Pediatric Cancer
| NCT ID | NCT06088030 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Yang Li |
| Condition | Pediatric Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-12-13 |
| Primary Completion | 2031-12-14 |
Eligibility & Interventions
Eligibility Fast-Check
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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 50 participants in total. It began in 2023-12-13 with a primary completion date of 2031-12-14.
⚠ 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 arsenic trioxide combined with chemotherapy for pediatric cancer with p53 mutation.
Eligibility Criteria
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.
Contact & Investigator
Yang Li, Professor
STUDY CHAIR
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Frequently Asked Questions
Who can join the NCT06088030 clinical trial?
This trial is open to participants of all sexes, up to 18 Years, studying Pediatric Cancer. 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 NCT06088030 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 NCT06088030 currently recruiting?
Yes, NCT06088030 is actively recruiting participants. Contact the research team at drliyang@126.com for enrollment information.
Where is the NCT06088030 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06088030 clinical trial?
NCT06088030 is sponsored by Yang Li. The principal investigator is Yang Li, Professor at Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. The trial plans to enroll 50 participants.
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