[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100540060":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":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Tongji Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Combined adjuvant therapy group","EXPERIMENTAL","Patients in the combined adjuvant therapy group received PD-1 monoclonal antibody with Lenvatinb adjuvant therapy after liver resection.",[13],"Drug: PD-1 monoclonal antibody and lenvatinib",{"label":15,"type":16,"description":17,"interventionNames":18},"Monotherapy group","ACTIVE_COMPARATOR","Patients in the monotherapy group received PD-1 monotherapy after liver resection.",[19],"Drug: PD-1 monoclonal antibody",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","PD-1 monoclonal antibody and lenvatinib","Patient receives first adjuvant PD-1 monoclonal antibody 2-4 weeks postoperatively, 200 mg IV, every 21 days for a total of 9 cycles; lenvatinib is initiated orally 2-4 weeks postoperatively for 6 months.",[9],[27],"Non",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"PD-1 monoclonal antibody","Patient receives first adjuvant PD-1 monoclonal antibody 2-4 weeks postoperatively, 200mg IV over 21 days for 9 cycles.",[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","100540060","phase-4-precision-adjuvant-therapy-after-surgery-for-hepatocellular-carcinoma-100540060",false,"NCT06311929","Precision Adjuvant Therapy After Surgery for Hepatocellular Carcinoma","VETC-based Precision Adjuvant Therapy for Postoperative Hepatocellular Carcinoma: 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. How to improve the prognosis of this group of patients is an urgent issue to be addressed.",[83],"HCC",[83,85,86,87,88],"Adjuvant therapy","VETC","PD-1 inhibitor","Lenvatinib","2024-05-05",{"date":91,"type":92},"2024-05-07","ACTUAL",{"date":94,"type":92},"2024-04-01",{"date":96,"type":77},"2028-12-31",{"name":63,"class":6},1]