[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616041":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":53,"centralContacts":61,"locations":70,"responsibleParty":94,"collaborators":36,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":36,"eligibilityCriteria":103,"healthyVolunteers":99,"sex":104,"minAge":36,"maxAge":105,"enrollmentInfo":106,"targetDuration":36,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":73,"whyStopped":36,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8,15,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1: Very low-risk group","EXPERIMENTAL","The study used CHIC staging to stage hepatoblastoma",[13,14],"Drug: Very low-risk group","Other: 5hmc dynamic monitoring",{"label":16,"type":10,"description":17,"interventionNames":18},"Arm 2: low risk group","Patients received 2 to 4 courses of DDP monotherapy followed by elective surgery, then 2 additional courses of DDP monotherapy postoperatively, totaling 4 to 6 treatment cycles.",[19,14],"Drug: Low-risk group",{"label":21,"type":10,"description":22,"interventionNames":23},"Arm 3：intermediate risk group","Treatment protocol randomization: Group A received SIOPEL-3 HR chemotherapy for 2-4 cycles followed by elective surgery, with continued chemotherapy for 6 additional cycles postoperatively.\n\nThe patients in group B were given C5VD chemotherapy for 2-4 courses and then underwent elective operation.",[24,14],"Drug: Intermediate-risk group",{"label":26,"type":10,"description":27,"interventionNames":28},"Arm 4： High risk group","Surgical resection after 3-5 courses of C-CD+ICE+solanifin chemotherapy",[29,14],"Drug: High-risk group",[31,37,41,45,49],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","Very low-risk group","Very low-risk group: No chemotherapy after pure fetal type surgery, followed up and observed. Chemotherapy with other types of single-agent DDP regimens for 4 courses.",[9],null,{"type":32,"name":38,"description":39,"armGroupLabels":40,"otherNames":36},"Low-risk group","Low-risk group: 2 to 4 courses of DDP monotherapy chemotherapy, elective surgery, 2 courses of DDP monotherapy chemotherapy after surgery, totaling 4 to 6 courses.",[16],{"type":32,"name":42,"description":43,"armGroupLabels":44,"otherNames":36},"Intermediate-risk group","Intermediate risk group: randomized treatment: group A SIOPEL - 3 HR solutions can be 2 \\~ 4 course of chemotherapy, continue to A total of 6 course of chemotherapy after surgery. Group B C5VD solution after 2 \\~ 4 course of chemotherapy, elective surgical procedures continue to a total of 6 course of chemotherapy after surgery.",[21],{"type":32,"name":46,"description":47,"armGroupLabels":48,"otherNames":36},"High-risk group","High-risk group：Chemotherapy with the C-CD+ICE+ sorafenib regimen for 3 to 5 courses was followed by elective surgery, with a total of 6 to 7 courses",[26],{"type":6,"name":50,"description":51,"armGroupLabels":52,"otherNames":36},"5hmc dynamic monitoring","Peripheral blood was regularly drawn from patients in the very low-risk group, low-risk group, intermediate-risk group and high-risk group for 5hmc dynamic monitoring to evaluate its value in clinical efficacy and recurrence detection",[9,16,21,26],[54,58],{"name":55,"affiliation":56,"role":57},"Junting Huang","SunYat Sen University Cancer Center","PRINCIPAL_INVESTIGATOR",{"name":59,"affiliation":56,"role":60},"Huang","STUDY_DIRECTOR",[62,67],{"name":63,"role":64,"phone":65,"phoneExt":36,"email":66},"Yizhuo Zhang, PhD","CONTACT","02087342460","wangjuan@sysucc.org.cn",{"name":68,"role":64,"phone":65,"phoneExt":36,"email":69},"Junting Huang, PhD","huangjt@sysucc.org.cn",[71,85],{"facility":72,"status":73,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":36},"Sun Yat-sen University Cancer Center","RECRUITING","Guangzhou","Guangdong","510060","China","CN",{"type":80,"coordinates":81},"Point",[82,83],113.25,23.11667,{"lat":83,"lon":82},{"facility":72,"status":73,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":86,"geoPoint":88,"contacts":89},{"type":80,"coordinates":87},[82,83],{"lat":83,"lon":82},[90],{"name":91,"role":64,"phone":92,"phoneExt":36,"email":93},"Yizhuo Yizhuo Zhang, PhD","020-87342460","zhangyzh@sysucc.org.cn",{"type":57,"investigatorFullName":95,"investigatorTitle":96,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"Yizhuo Zhang","Prof","100616041","phase-2-a-prospective-multicenter-clinical-study-of-sccg-protocol-and-ctdna-5hmc-in-predicting-the-chemotherapy-sensitivity-and-monitoring-the-recurrence-and-metastasis-of-hepatoblastoma-in-children-and-adolescents-100616041",false,"NCT07300449","A Prospective Multicenter Clinical Study of SCCG Protocol and ctDNA 5hmc in Predicting the Chemotherapy Sensitivity and Monitoring the Recurrence and Metastasis of Hepatoblastoma in Children and Adolescents","A Prospective Multicenter Clinical Study of the South China Collaborative Group Protocol for the Treatment of Hepatoblastoma in Children and Adolescents","Inclusion Criteria:\n\n* Patients with primary hepatoblastoma confirmed by pathology.\n\n  * The age of the subjects was less than 18 years old. ③ Obtain the informed consent from the guardians and sign the informed consent form\n\nExclusion Criteria:\n\n* Recurrent hepatoblastoma or other malignant tumor.\n\n  * Age\\> 18 years old. ③ Patients with other tumors and received chemotherapy and abdominal radiotherapy.\n\n    * Heart, brain and kidney failure patients.","ALL","18 Years",{"count":107,"type":108},100,"ESTIMATED","INTERVENTIONAL",[111],"PHASE2","Hepatoblastoma is the most common malignant liver tumor in infants and preschool children, comprising 65% of pediatric liver malignancies in those under 15, with its incidence on the rise in recent years \\[1\\]. Standard therapy combines surgical resection and chemotherapy: early-stage patients boast a survival rate over 90%, yet high-risk cases only reach around 40%, highlighting unmet treatment needs.\n\nNotably, there is no universal definition for high-risk hepatoblastoma. The U.S. COG (AHEP0731) categorizes it as stage 4 disease, AFP \\\u003C100ng\u002Fml at diagnosis (any stage), or small cell undifferentiated histology; conversely, SIOP includes factors like major vascular invasion (inferior vena cava\u002Fportal vein), intra-abdominal extrahepatic spread, distant metastasis, AFP \\\u003C100ng\u002Fml, or tumor rupture, regardless of PRETEXT stage. To improve outcomes, international teams have tested intensified chemotherapy: Europe's SIOPEL reported that escalated cisplatin-doxorubicin regimens lifted high-risk patients' 3-year overall survival to over 80% \\[2\\], though with heightened toxicity. Similarly, Germany's IPA (ifosfamide-cisplatin-doxorubicin) and Japan's ITEC (ifosfamide-doxorubicin-carboplatin-VP-16) regimens delivered significant survival benefits but also amplified side effects \\[3,4\\].\n\nAgainst this backdrop, the Guangdong Anti-Cancer Association's Pediatric Oncology Committee, led by Sun Yat-sen University Cancer Center and involving 15 hospitals, is launching a multicenter prospective trial to identify optimal chemotherapy regimens for Chinese hepatoblastoma children.\n\nParallelly, liquid biopsy has become an oncology research priority, offering four core advantages over tissue biopsy: non-invasiveness (peripheral blood sampling avoids tumor seeding), real-time genetic\u002Fprogression monitoring (eliminating repeated invasive procedures), comprehensive molecular profiling (overcoming intratumoral heterogeneity), and high accuracy (capturing primary tumor-derived data). Given hepatoblastoma's propensity for early distant metastasis and 30-40% advanced-stage survival (with limited late-stage chemo efficacy), the Nano-5hmC-Seal cfDNA epigenetic profiling method holds promise as a novel biomarker for early diagnosis, treatment prediction, recurrence monitoring, and prognosis assessment in this disease.",[114],"Hepatoblastoma",[116],"hepatoblastoma","2025-12-10",{"date":119,"type":120},"2025-12-23","ACTUAL",{"date":122,"type":120},"2021-06-23",{"date":124,"type":108},"2028-12-31",{"name":5,"class":6},2]