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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Maximum Age: 18
Healthy Volunteers: f
View:
• Pathological diagnosis basis of malignant tumor；
• Patients not more than 18 years old;
• 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);
• There are measurable lesions;
• Guardians agreed and signed informed consent.
Locations
Other Locations
China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
RECRUITING
Guangzhou
Contact Information
Primary
Yang Li, Professor
drliyang@126.com
+8602081332456
Time Frame
Start Date: 2023-12-13
Estimated Completion Date: 2031-12-14
Participants
Target number of participants: 50
Treatments
Experimental: Arsenic trioxide combined chemotherapy
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.
Related Therapeutic Areas
Sponsors
Collaborators: Ruijin Hospital
Leads: Yang Li