[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522854":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":32,"responsibleParty":49,"collaborators":53,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":30,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":30,"maxAge":64,"enrollmentInfo":65,"targetDuration":30,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":76,"overallStatus":35,"whyStopped":30,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Arsenic trioxide combined chemotherapy","EXPERIMENTAL","Patients with p53-mutated pediatric cancer should initially undergo the corresponding first-line chemotherapy regimen. If the patient is evaluated as PD\u002FSD, arsenic trioxide (ATO) will be administered in conjunction with previous conventional chemotherapy on the third day of each treatment cycle.",[13],"Drug: Arsenic trioxide",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Arsenic trioxide","Patients should be treated with the corresponding first-line chemotherapy regimen first, for example: Neuroblastoma: CAV (cyclophosphamide, pinarubicin, vincristine), PVP (cisplatin, etoposide) ,CT (cyclophosphamide, topotecan).If patients was evaluted as PD\u002FSD after treatments, arsenic trioxide (ATO) will be administered 0.18mg\u002Fkg per day over six hours IV daily for ten days in combination with previous chemotherapy regimen on the third day of each treatment cycle. Other pediatric tumors with TP53 mutations not mentioned above will have similar treatment regimens. If the efficacy of the conventional standard chemotherapy regimen is evaluated as PD\u002FSD, then the next course of treatment will be combined with ATO on the basis of the standard chemotherapy regimen.",[9],[21],"ATO",[23],{"name":24,"affiliation":5,"role":25},"Yang Li, Professor","STUDY_CHAIR",[27],{"name":24,"role":28,"phone":29,"phoneExt":30,"email":31},"CONTACT","+8602081332456",null,"drliyang@126.com",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Sun Yat-sen Memorial Hospital, Sun Yat-sen University","RECRUITING","Guangzhou","Guangdong","510120","China","CN",{"type":42,"coordinates":43},"Point",[44,45],113.25,23.11667,{"lat":45,"lon":44},[48],{"name":24,"role":28,"phone":29,"phoneExt":30,"email":31},{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"SPONSOR_INVESTIGATOR","Yang Li","Professor",[54],{"name":55,"class":6},"Ruijin Hospital","100522854","phase-2-arsenic-trioxide-combined-with-chemotherapy-for-the-treatment-of-p53-mutated-pediatric-cancer-100522854",false,"NCT06088030","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","Inclusion Criteria:\n\n1. Pathological diagnosis basis of malignant tumor；\n2. Patients not more than 18 years old;\n3. Patient has either germline or somatic p53 mutations, which was shown to be partially\u002Fcompletely restored to function by ATO in in vitro experiments (http:\u002F\u002Fwww.rescuep53.net);\n4. There are measurable lesions;\n5. Guardians agreed and signed informed consent.\n\nExclusion Criteria:\n\nPatients with one or more critical organs failure such as heart, brain, kidney failure.","ALL","18 Years",{"count":66,"type":67},50,"ESTIMATED","INTERVENTIONAL",[70],"PHASE2","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.",[73,74,75],"Pediatric Cancer","Li-Fraumeni Syndrome","p53 Mutations",[77],"Arsenic Trioxide","2024-01-02",{"date":80,"type":81},"2024-01-03","ACTUAL",{"date":83,"type":81},"2023-12-13",{"date":85,"type":67},"2031-12-14",{"name":51,"class":6},1]