[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574602":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":22,"centralContacts":31,"locations":37,"responsibleParty":53,"collaborators":22,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":22,"eligibilityCriteria":62,"healthyVolunteers":59,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":22,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":77,"overallStatus":40,"whyStopped":22,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Liposomal Mitoxantrone Combination Regimen","EXPERIMENTAL","Mitoxantrone liposome+Capecitabine+Anlotinib",[13,14,15],"Drug: Mitoxantrone liposome","Drug: Capecitabine","Drug: Anlotinib",[17,23,27],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","Mitoxantrone liposome","Mitoxantrone liposome: 16 mg\u002Fm\\^2, d1; Each 21-day cycle was used for a total of 4-6 cycles.",[9],null,{"type":18,"name":24,"description":25,"armGroupLabels":26,"otherNames":22},"Capecitabine","Capecitabine 1000 mg\u002Fm\\^2, d1-14, bid; Each 21-day cycle was used for a total of 4-6 cycles.",[9],{"type":18,"name":28,"description":29,"armGroupLabels":30,"otherNames":22},"Anlotinib","Anlotinib: according to patient weight: 8mg\u002F day in patients \\\u003C35kg; 10mg\u002F day for patients with 35kg≤ patient weight ≤50kg; 12mg\u002F day for patients \\> 50kg; d1-14; Each 21-day cycle was used for a total of 4-6 cycles.",[9],[32],{"name":33,"role":34,"phone":35,"phoneExt":22,"email":36},"Sidan Li","CONTACT","+86-0316-5917421","lisidan2006@126.com",[38],{"facility":39,"status":40,"city":41,"state":22,"zip":22,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Cancer Hospital, Chinese Academy of Medical Sciences","RECRUITING","Beijing","China","CN",{"type":45,"coordinates":46},"Point",[47,48],116.39723,39.9075,{"lat":48,"lon":47},[51],{"name":33,"role":34,"phone":52,"phoneExt":22,"email":36},"01087788559",{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","SIDAN LI","Prof","100574602","phase-2-a-prospective-single-arm-clinical-study-of-liposomal-mitoxantrone-combination-regimen-in-the-treatment-of-relapsed-and-refractory-solid-tumors-in-children-adolescents-and-young-adults-100574602",false,"NCT06761417","A Prospective, Single-arm Clinical Study of Liposomal Mitoxantrone Combination Regimen in the Treatment of Relapsed and Refractory Solid Tumors in Children, Adolescents and Young Adults","Main inclusion Criteria:\n\n1. The patient fully understands this study, voluntarily participates and signs the informed consent form (ICF).\n2. Age: children (6 - 12 years old), adolescents (13 - 18 years old) and young adults (19 - 24 years old) (CAYA). The expected survival time is \\> 3 months.\n3. Diagnosed with relapsed and refractory solid tumors by histopathology, and it is one of the following subtypes: (1) bone and soft tissue tumors; (2) neuroblastoma; (3) other types of solid tumors that the investigator deems eligible for enrollment.\n4. There must be measurable tumor lesions by CT, enhanced CT, PET\u002FCT or MRI.\n5. Karnofsky score \\> 50; ECOG score ≤ 2.\n6. Bone marrow function: neutrophil count \\> 1.5 × 10⁹\u002FL, platelet count \\> 75 × 10⁹\u002FL, hemoglobin ≥ 80 g\u002FL.\n7. Liver and kidney function: serum creatinine ≤ 1.5 times the upper limit of normal value; AST and ALT \\\u003C 2.5 times the upper limit of normal value (for patients with liver invasion \\\u003C 5 times the upper limit of normal value); total bilirubin \\\u003C 1.5 times the upper limit of normal value (for patients with liver invasion \\\u003C 3 times the upper limit of normal value).\n8. No history of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, no history of clinically severe pericardial disease, or no electrocardiogram evidence of acute ischemic or active conduction system abnormality within 6 months before recruitment.\n\nMain exclusion Criteria:\n\n1. Patients with known hypersensitivity to any component of the study drugs.\n2. Patients with other malignant tumors that are not under control (except for basal cell carcinoma of the skin, in-situ breast\u002Fcervical cancer, and other malignant tumors that have been effectively controlled without treatment in the past five years).\n3. Pregnant, lactating women and women of childbearing age who are unwilling to take contraceptive measures.\n4. Other situations judged by the investigator as not suitable for participating in this study.","ALL","6 Years","24 Years",{"count":67,"type":68},49,"ESTIMATED","INTERVENTIONAL",[71],"PHASE2","The aim of this clinical study is to determine the efficacy and safety of the liposomal mitoxantrone combination regimen in treating relapsed and refractory solid tumors among children, adolescents, and young adults. The key questions it intends to address are:\n\nCan the liposomal mitoxantrone combination regimen improve the objective response rate (ORR) compared to historical data? What are the adverse events associated with this combination regimen? Researchers will administer the liposomal mitoxantrone combination regimen (including capecitabine and anlotinib with specific dosing regimens) to the participants and closely monitor their conditions.\n\nParticipants will:\n\nReceive the treatment regimen for 4 - 6 cycles, with each cycle lasting 21 days Undergo regular checkups and tests during the treatment period and follow-up period as per the protocol.\n\nHave their tumor status, blood parameters, and other relevant indicators measured to evaluate the treatment effect and safety.",[74,75,76],"Solid Tumors","Children","Adolescents",[78,79,80],"Mitoxantrone liposomes","Solid tumor","Children and adolescents","2026-05-06",{"date":83,"type":84},"2026-05-07","ACTUAL",{"date":86,"type":84},"2025-01-24",{"date":88,"type":68},"2028-02-01",{"name":5,"class":6},1]