[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100540061":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":44,"responsibleParty":61,"collaborators":42,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":42,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":42,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":47,"whyStopped":42,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Tongji Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Triple adjuvant therapy group","EXPERIMENTAL","Patients in the triple adjuvant therapy group received HAIC in combination with PD-1 inhibitors and lenvatinib adjuvant therapy.",[13],"Drug: HAIC plus PD-1 inhibitors plus lenvatinib",{"label":15,"type":16,"description":17,"interventionNames":18},"Dual adjuvant therapy group","ACTIVE_COMPARATOR","Patients in the Dual adjuvant therapy group received PD-1 inhibitors combined lenvatinib adjuvant therapy.",[19],"Drug: PD-1 inhibitors plus lenvatinib",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","HAIC plus PD-1 inhibitors plus lenvatinib","Patients in the triple adjuvant therapy group received one cycle of HAIC about a month after liver resection, HAIC was adopted the FOFOLX6 program (Folinic acid+5-fluorouracil+Oxaliplatin). The first cycle of PD-1 monoclonal antibody was administrated 2-4 weeks postoperatively, 200 mg IV, every 21 days for a total of 9 cycles. Lenvatinib was initiated orally 2-4 weeks postoperatively for 6 months.",[9],[27],"Non",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"PD-1 inhibitors plus lenvatinib","The first cycle of PD-1 monoclonal antibody was administrated 2-4 weeks postoperatively, 200 mg IV, every 21 days for a total of 9 cycles. Lenvatinib was initiated orally 2-4 weeks postoperatively for 6 months.",[15],[27],[34],{"name":35,"affiliation":5,"role":36},"xiaoping Chen","PRINCIPAL_INVESTIGATOR",[38],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},"WanGuang Zhang","CONTACT","+8613886195965",null,"wgzhang@tjh.tjmu.edu.cn",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China","RECRUITING","Wuhan","Hubei","430000","China","CN",{"type":54,"coordinates":55},"Point",[56,57],114.26667,30.58333,{"lat":57,"lon":56},[60],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},{"type":62,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"SPONSOR_INVESTIGATOR","Chen Xiaoping","Professor","100540061","phase-4-triple-vs-dual-adjuvant-therapy-following-liver-resection-for-hcc-100540061",false,"NCT06311942","Triple vs. Dual Adjuvant Therapy Following Liver Resection for HCC.","Effectiveness of Triple Versus Dual Adjuvant Therapy in VETC-positive Population Following Liver Resection for HCC: a Prospective Multicenter Cohort Study","Inclusion Criteria:\n\n1. Aged 18-75.\n2. No previous local or systemic treatment for hepatocellular carcinoma.\n3. Child-Pugh liver function score ≤ 7.\n4. ECOG PS 0-1.\n5. No serious organic diseases of the heart, lungs, brain, kidneys, etc.\n6. Pathologic type is hepatocellular carcinoma .\n7. Confirmation of the presence of VETC vascular pattern by CD34 immunohistochemical staining.\n\nExclusion Criteria:\n\n1. Pregnant and lactating women.\n2. Suffering from a condition that interferes with the absorption, distribution, metabolism, or clearance of the study drug (e.g., severe vomiting, chronic diarrhea, intestinal obstruction, impaired absorption, etc.).\n3. A history of gastrointestinal bleeding within the previous 4 weeks or a definite predisposition to gastrointestinal bleeding (e.g., known locally active ulcer lesions, fecal occult blood ++ or more, or gastroscopy if persistent fecal occult blood +) that has not been targeted, or other conditions that may have caused gastrointestinal bleeding (e.g., severe fundoplication\u002Fesophageal varices), as determined by the investigator.\n4. Active infection.\n5. Other significant clinical and laboratory abnormalities that affect the safety evaluation.\n6. Inability to follow the study protocol for treatment or follow up as scheduled.","ALL","18 Years","75 Years",{"count":76,"type":77},300,"ESTIMATED","INTERVENTIONAL",[80],"PHASE4","Vessels that encapsulate tumor clusters (VETC) is an invasive metastatic factor in HCC independent of the epithelial mesenchyme transition (EMT), and VETC-positive patients have a higher rate of postoperative recurrence. What can be done to improve the surgical prognosis of this group of patients needs to be continuously explored.",[83],"HCC",[83,85,86,87,88,89],"Adjuvant therapy","VETC","HAIC","Lenvatinib","PD-1 inhibitors","2024-05-05",{"date":92,"type":93},"2024-05-07","ACTUAL",{"date":95,"type":93},"2024-04-01",{"date":97,"type":77},"2028-12-31",{"name":63,"class":6},1]