[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634305":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":51,"collaborators":26,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":26,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":26,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":75,"overallStatus":80,"whyStopped":26,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Tongji Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Systemic Therapy Alone","ACTIVE_COMPARATOR","Participants receive protocol-allowed first-line immune-based systemic therapy without planned primary tumor resection. Optional HAIC may be used according to clinical need and will be recorded. Unplanned surgery after randomization will be recorded but will not change the original group assignment for the primary analysis.",[13],"Other: Protocol-Allowed First-Line Immune-Based Systemic Therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Primary Tumor Resection Plus Systemic Therapy","EXPERIMENTAL","Participants undergo resection of the primary intrahepatic tumor with curative intent (R0 intent) followed by protocol-allowed first-line immune-based systemic therapy after adequate postoperative recovery. Optional HAIC may be used according to clinical need and will be recorded.",[19,13],"Procedure: Primary Tumor Resection",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Primary Tumor Resection","Surgical resection of the primary liver tumor with curative intent (R0 intent), using anatomic or non-anatomic hepatectomy as appropriate based on tumor location, liver reserve, and operative risk.",[15],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Protocol-Allowed First-Line Immune-Based Systemic Therapy","Guideline-concordant first-line immune-based systemic therapy. Preferred regimens include PD-1\u002FPD-L1 inhibitor plus anti-angiogenic therapy. PD-1 inhibitor plus multikinase targeted therapy is allowed when anti-angiogenic therapy is contraindicated or not feasible. Concurrent use of more than one PD-1\u002FPD-L1 agent is not permitted.",[15,9],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Zhao Huang, M.D","CONTACT","+86 13006378908","huangzhao@tjh.tjmu.edu.cn",[38],{"facility":39,"status":26,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":26},"Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology","Wuhan","Hubei","430030","China","CN",{"type":46,"coordinates":47},"Point",[48,49],114.26667,30.58333,{"lat":49,"lon":48},{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Chen Xiaoping","professor","100634305","surgery-plus-systemic-therapy-for-liver-cancer-with-extrahepatic-metastases-100634305",false,"NCT07537959","Surgery Plus Systemic Therapy for Liver Cancer With Extrahepatic Metastases","Primary Tumor Resection Plus Systemic Therapy Versus Systemic Therapy Alone in Hepatocellular Carcinoma With Extrahepatic Metastases: A Multicenter Prospective Randomized Controlled Trial","Inclusion Criteria:\n\n* Age 18 to 75 years\n* Hepatocellular carcinoma confirmed by imaging and\u002For histology according to AASLD or EASL criteria\n* Resectable primary intrahepatic tumor with expected R0 resection\n* ECOG performance status 0 to 1\n* At least one measurable extrahepatic metastatic lesion according to RECIST version 1.1\n* Child-Pugh class A or stable Child-Pugh B7\n* Written informed consent and willingness to comply with study follow-up and data collection\n\nExclusion Criteria:\n\n* Prior systemic therapy for hepatocellular carcinoma, including immunotherapy, targeted therapy, or chemotherapy\n* Decompensated or clinically unstable liver disease, including refractory ascites, recurrent hepatic encephalopathy, active gastrointestinal bleeding, or - Child-Pugh class greater than B7\n* Major bleeding risk or clinically significant coagulation abnormality, including recent gastrointestinal bleeding or untreated\u002Fhigh-risk gastroesophageal varices\n* Active autoimmune disease or long-term systemic immunosuppressive therapy\n* Active severe infection, including uncontrolled bacterial or fungal infection, uncontrolled hepatitis B virus replication without appropriate antiviral treatment, or active tuberculosis\n* Uncontrolled central nervous system metastases\n* Uncontrolled cardiovascular disease, including poorly controlled hypertension, recent myocardial infarction, unstable angina, stroke, or major thrombotic event\n* Significant proteinuria or renal dysfunction considered unsuitable for study treatment\n* Another active malignancy, except for selected low-risk malignancies allowed by the investigator and ethics committee\n* Pregnancy or breastfeeding\n* Known severe hypersensitivity to study-related drugs\n* Poor compliance, psychiatric or cognitive disorder preventing study participation, or any other condition judged by the investigator to make the participant unsuitable for the trial","ALL","18 Years","75 Years",{"count":66,"type":67},280,"ESTIMATED","INTERVENTIONAL",[70],"NA","This study will evaluate whether resection of the primary liver tumor, in addition to standard first-line systemic therapy, improves survival in patients with hepatocellular carcinoma that has spread outside the liver but still has a resectable primary intrahepatic tumor. Participants will be randomly assigned to receive either primary tumor resection followed by protocol-allowed first-line immune-based systemic therapy or systemic therapy alone. The primary outcome is overall survival. Secondary outcomes include progression-free survival, objective response rate, disease control rate, immune-related adverse events, postoperative complications, and quality of life.",[73,74],"Hepatocellular Carcinoma (HCC)","Metastasis",[76,77,23,78,79],"Hepatocellular Carcinoma","Extrahepatic Metastases","Systemic Therapy","Immunotherapy","NOT_YET_RECRUITING","2026-04-12",{"date":83,"type":84},"2026-04-17","ACTUAL",{"date":86,"type":67},"2026-04-30",{"date":88,"type":67},"2031-04-30",{"name":5,"class":6},1]