[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560758":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":31,"locations":36,"responsibleParty":53,"collaborators":18,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":18,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":18,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":75,"overallStatus":39,"whyStopped":18,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A (Donafenib)","EXPERIMENTAL","Participants will receive Donafenib treatment until disease recurrence or unacceptable toxicity or up to 1 years.",[13],"Drug: Donafenib",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm B (active surveillance)","NO_INTERVENTION","Active surveillance of participants.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Donafenib","Donafenib 100 mg twice daily (BID)",[9],[26],"Zepsun",[28],{"name":29,"affiliation":5,"role":30},"Changzhen Shang, MD","PRINCIPAL_INVESTIGATOR",[32],{"name":29,"role":33,"phone":34,"phoneExt":18,"email":35},"CONTACT","+86-20-3407 0701","shchzh2@mail.sysu.edu.cn",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Sun Yat-sen Memorial Hospital of Sun Yat-sen University","RECRUITING","Guangzhou","Guangdong","510120","China","CN",{"type":46,"coordinates":47},"Point",[48,49],113.25,23.11667,{"lat":49,"lon":48},[52],{"name":29,"role":33,"phone":34,"phoneExt":18,"email":35},{"type":54,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100560758","postoperative-adjuvant-therapy-of-donafenib-for-hepatocellular-carcinoma-100560758",false,"NCT06581315","Postoperative Adjuvant Therapy of Donafenib for Hepatocellular Carcinoma","Efficacy and Safety of Donafenib as Adjuvant Therapy for Postoperative Patients With High-Risk Recurrent Hepatocellular Carcinoma: A Multicenter, Randomized Controlled Study","Inclusion Criteria:\n\n* Participants underwent radical resection of hepatocellular carcinoma 4 weeks before randomization\n* High Risk of recurrence as assessed by tumor characteristics\n* Without any anti-tumor therapy before surgery, except preoperative TACE therapy, traditional Chinese medicine therapy and interferon therapy\n* Child-Pugh Class A statu\n* ECOG Performance Status of 0 or 1\n* CT\u002FMR confirmed no recurrence or metastasis at ≥4 weeks after surgery\n* Expected survival time of no less than 3 months\n\nExclusion Criteria:\n\n* Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC\n* Evidence of residual or a history of spontaneous tumor rupture\n* Recurrent HCC\n* Prior received Liver transplantation\n* Prior anti tumor therapy for treatment of HCC (including sorafenib or any other molecular therapy, anti-PD-1 antibody and other immunotherapies, FOLFOX systemic chemotherapy) is excluded\n* AFP does not return to normal 4 weeks after operation","ALL","18 Years","75 Years",{"count":66,"type":67},204,"ESTIMATED","INTERVENTIONAL",[70],"NA","This study aims to evaluate the efficacy and safety of donafenib as adjuvant therapy for postoperative patients with high-risk recurrent Hepatocellular Carcinoma. This is a multicenter, randomized controlled study.",[73,74],"Hepatocellular Carcinoma","Adjuvant Therapy",[73,74],"2024-08-30",{"date":78,"type":79},"2024-09-03","ACTUAL",{"date":81,"type":67},"2024-08-28",{"date":83,"type":67},"2032-08-30",{"name":5,"class":6},1]