[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100531874":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":46,"collaborators":19,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":19,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":19,"enrollmentInfo":58,"targetDuration":19,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":69,"overallStatus":29,"whyStopped":19,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Adjuvant SIB radiotherapy","EXPERIMENTAL","Adjuvant integrated boost radiotherapy following narrow-margin hepatectomy in patients with HCC.",[13],"Radiation: Adjuvant SIB radiotherapy",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"RADIATION","Eligibility patients will receive IMRT or VMAT to high risk area of tumor bed and tumor bed. The prescription dose to 95% GTVtb boost was planned at 55-60Gy, with PTV 45-50Gy, in 23-25 fractions,mainly depending on the dose constraints of OARs.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Bo Chen, MD","CONTACT","00861324000876","chenboo@outlook.com",[27],{"facility":28,"status":29,"city":30,"state":19,"zip":19,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Bo Chen","RECRUITING","Beijing","China","CN",{"type":34,"coordinates":35},"Point",[36,37],116.39723,39.9075,{"lat":37,"lon":36},[40,41,44],{"name":28,"role":23,"phone":24,"phoneExt":19,"email":25},{"name":42,"role":43,"phone":19,"phoneExt":19,"email":19},"Yirui Zhai","SUB_INVESTIGATOR",{"name":28,"role":45,"phone":19,"phoneExt":19,"email":19},"PRINCIPAL_INVESTIGATOR",{"type":45,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"BO CHEN","Associate Professor","100531874","phase-2-phase-ii-study-of-adjuvant-sib-radiotherapy-following-narrow-margin-hepatectomy-in-patients-with-hcc-100531874",false,"NCT06205472","Phase II Study of Adjuvant SIB Radiotherapy Following Narrow-Margin Hepatectomy in Patients With HCC.","Phase II Study of Adjuvant Simultaneously Integrated Boost Radiotherapy Following Narrow-Margin Hepatectomy in Patients With HCC.","Inclusion Criteria:\n\n* Pathological diagnosis of HCC after hepatectomy with narrow pathological margins (\\\u003C 1 cm)\n* Age \\> 18 years\n* Recovery from surgery with an Eastern Cooperative Oncology Group performance status score of 0 or 1\n* Child-Push Score: A5-A6\n* Estimated life expectancy \\> 3 months\n* No distant metastasis (M0)\n* Blood routine examination: Hb≥80g\u002FL, ANC≥1.0x10\\^9\u002FL, PLT≥50x10\\^9\u002FL\n* Hepatic function: alanine transaminase(ALT) and aspartate transaminase(AST) ≤1.5 times ULN; or ALT ≤ULN and AST ≤6 times ULN exclude possibility of heart disease\n* Renal function: creatinine(CRE) and blood urea nitrogen(BUN)≤1.5 times ULN\n* Voluntary to participate and sign informed consent\n\nExclusion Criteria:\n\n* History of malignancies, except for basal cell skin carcinoma and in situ carcinoma of the cervix\n* Had prior abdominal irradiation\n* Had prior liver transplantation\n* Had serious myocardial disease or renal failure\n* Had moderate or severe ascites with obvious symptoms\n* Duration from surgery ≥ 3 months","ALL","18 Years",{"count":59,"type":60},100,"ESTIMATED","INTERVENTIONAL",[63],"PHASE2","This is a single-arm prospective phase II clinical trial to investigate the efficacy and safety of adjuvant simultaneouslyintegrated boost radiotherapy following narrow-margin(\\\u003C1cm) hepatectomy in patients with HCC. Eligibility patients will receive IMRT or VMAT to high risk area of tumor bed and tumor bed. The prescription dose to 95% GTVtb boost was planned at 55-60Gy, with PTV 45-50Gy, in 23-25 fractions, mainly depending on the dose constraints of OARs. The primary endpoint is the 3-year OS, the secondary endpoints are disease-free survival, patterns of failure, toxic events and local control rate.",[66,67,68],"Hepatocellular Carcinoma","Narrow Margin","Radiotherapy",[66,67,70],"Adjuvant Simultaneously Integrated Boost Radiotherapy","2024-01-11",{"date":73,"type":74},"2024-01-16","ACTUAL",{"date":76,"type":60},"2024-01-26",{"date":78,"type":60},"2026-12-12",{"name":5,"class":6},1]