[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100517136":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":67,"centralContacts":72,"locations":83,"responsibleParty":104,"collaborators":107,"id":110,"slug":111,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":114,"acronym":77,"eligibilityCriteria":115,"healthyVolunteers":112,"sex":116,"minAge":117,"maxAge":77,"enrollmentInfo":118,"targetDuration":77,"studyType":121,"phases":122,"briefSummary":124,"conditions":125,"keywords":77,"overallStatus":86,"whyStopped":77,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8,14,22],{"label":9,"type":6,"description":10,"interventionNames":11},"naxitamab and GM-CSF only","Suitable for patients with high risk neuroblastoma who obtain CR after chemotherapy combined with surgery, radiotherapy and\u002For hematopoietic stem cell transplantation. The treatment cycle is repeated every 4 weeks for a total of 5 courses, and discontinuation of nasetuzumab and GM-CSF should be considered if disease progression or unacceptable toxicity occurs.",[12,13],"Drug: Naxitamab monotherapy","Drug: GM-CSF",{"label":15,"type":6,"description":16,"interventionNames":17},"naxitamab and GM-CSF in combination with irinotecan and temozolomide","Suitable for high-risk group neuroblastoma treated by chemotherapy combined with surgery, radiotherapy and or hematopoietic stem cell transplantation patients with tumor residual or progression during treatment (refractory); Patients who relapse after initial treatment. Repeat every 3 weeks until tumor progression, patient withdrawal, or toxicity becomes intolerable, up to 8 procedures.",[18,19,20,21],"Drug: Irinotecan","Drug: Temozolomide","Drug: Naxitamab in combination therapy","Drug: GM-CSF with combination regimen",{"label":23,"type":6,"description":16,"interventionNames":24},"naxitamab and GM-CSF in combination with irinotecan and temozolomide and PD-1 antibody",[18,19,20,21,25],"Drug: Sintilimab",[27,34,40,46,51,56,61],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Naxitamab monotherapy","Naxitamab is administered on days 1, 3, and 5",[9],[33],"hu3F8",{"type":28,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"GM-CSF","Each treatment cycle is 28 days and is started with five days (days -4 to 0) of GM-CSF administered at 250 mcg\u002Fm2\u002Fday in advance of the start of naxitamab infusion. GM-CSF is thereafter administered at 500 mcg\u002Fm2\u002Fday on days 1 to 5.",[9],[39],"Recombinant Human Granulocyte\u002FMacrophage Colony-stimulating Factor",{"type":28,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"Irinotecan","Each HITS treatment cycle is 21 days. Irinotecan intravenously (IV) at 50 mg\u002Fm2\u002Fday will be administered from Day 1-5 concurrently with temozolomide orally at 150 mg\u002Fm2\u002Fday or 100 mg\u002Fm2\u002Fday.",[15,23],[45],"DNA topoisomerase I inhibitor",{"type":28,"name":47,"description":42,"armGroupLabels":48,"otherNames":49},"Temozolomide",[15,23],[50],"Temozolomide for Injection",{"type":28,"name":52,"description":53,"armGroupLabels":54,"otherNames":55},"Naxitamab in combination therapy","Naxitamab 2.25mg\u002Fkg IV will be administered on Days 2, 4, 8 and 10.",[15,23],[33],{"type":28,"name":57,"description":58,"armGroupLabels":59,"otherNames":60},"GM-CSF with combination regimen","GM-CSF 250 mcg\u002Fm2\u002Fday will be administered subcutaneously on Days 6-10.",[15,23],[39],{"type":28,"name":62,"description":63,"armGroupLabels":64,"otherNames":65},"Sintilimab","Sintilimab was administerd with 3mg\u002Fkg (max 200mg) on day 11 every 3 weeks.",[23],[66],"PD-1 antibody",[68],{"name":69,"affiliation":70,"role":71},"Yizhuo Zhang","SunYat Sen University Cancer Center","STUDY_CHAIR",[73,79],{"name":74,"role":75,"phone":76,"phoneExt":77,"email":78},"Yizhuo Zhang, MD","CONTACT","0087342460",null,"zhangyzh@sysucc.org.cn",{"name":80,"role":75,"phone":81,"phoneExt":77,"email":82},"Juan Wang","008687342660","wangjuan@sysucc.org.cn",[84],{"facility":85,"status":86,"city":87,"state":88,"zip":89,"country":90,"countryCode":91,"cosmosGeoPoint":92,"geoPoint":97,"contacts":98},"Sun Yat-sen University Cancer Center","RECRUITING","Guangzhou","Guangdong","510060","China","CN",{"type":93,"coordinates":94},"Point",[95,96],113.25,23.11667,{"lat":96,"lon":95},[99,102],{"name":100,"role":75,"phone":101,"phoneExt":77,"email":78},"Yi-Zhuo Zhang, MD","87342460",{"name":100,"role":103,"phone":77,"phoneExt":77,"email":77},"PRINCIPAL_INVESTIGATOR",{"type":103,"investigatorFullName":69,"investigatorTitle":105,"investigatorAffiliation":106,"oldNameTitle":77,"oldOrganization":77},"Director","Sun Yat-Sen University Cancer Center",[108],{"name":109,"class":6},"Hainan General Hospital","100517136","phase-2-clinical-analysis-of-naxitamab-hu3f8-in-the-treatment-of-pediatric-high-risk-or-refractory-relapsed-neuroblastoma-100517136",false,"NCT06013618","Clinical Analysis of Naxitamab (hu3F8) in the Treatment of Pediatric High Risk or Refractory\u002F Relapsed Neuroblastoma","Inclusion Criteria:\n\n1)Confirmed diagnosis of high-risk NB 2)1 year of age or above 3)Patient or parent\u002Fguardian must provide written informed consent to participate 4)If patient is sexually active, the patient agrees to use effective contraception 5)Confirmed negative urine pregnancy test for sexually active female of child-bearing potential (post-menarche)\n\nExclusion Criteria:\n\n1. Significant organ toxicity\n2. Known or suspected allergy or hypersensitivity to anti-GD2 antibodies or to GM-CSF or its s components.\n3. Patient is pregnant, planning to become pregnant (while being treated with naxitamab) or is currently breastfeeding\n4. Patient will undergo treatment with another investigational drug, whilst being treated with naxitamab or has received another investigational drug within the 4 weeks prior to commencing treatment with naxitamab\n5. Patient is either eligible and able to participate in or is currently participating in an active interventional Y-mAbs sponsored clinical trial with naxitamab within the indication applied for\n6. Patient is unable to comply with the naxitamab treatment or has a medical condition that would potentially increase the severity of the toxicities experienced from naxitamab treatment at the discretion of the treating physician\n7. Left ventricular ejection fraction of \\\u003C50% by echocardiography OR other clinically relevant cardiac disorders at the discretion of the investigator\n8. Inadequate pulmonary function defined as evidence of dyspnea at rest, exercise intolerance, and\u002For chronic oxygen requirement. In addition, room air pulse oximetry \\\u003C 94% and\u002For abnormal pulmonary function tests if these assessments are clinically indicated\n\n   Applicable for treatment with naxitamab in combination with GM-CSF only:\n9. Patient has active progression of the NB disease\n10. Patient has active NB disease at primary site or soft-tissue metastasis\n11. Patient has known CNS metastases when initiating naxitamab treatment","ALL","12 Months",{"count":119,"type":120},120,"ESTIMATED","INTERVENTIONAL",[123],"PHASE2","This is an prospective study to evaluate the safety and efficacy of naxitamab monotherapy or combined with chemotherapy or combined with chemotherapy and checkpoint inhibitor in the treatment of pediatric high-risk and refractory\u002Frelapsed neuroblastoma in Sun Yat-sen University Cancer Center.",[126],"Neuroblastoma","2025-06-13",{"date":129,"type":130},"2025-06-17","ACTUAL",{"date":132,"type":130},"2023-06-19",{"date":134,"type":120},"2027-12-31",{"name":106,"class":6},1]