[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648744":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":10,"centralContacts":40,"locations":46,"responsibleParty":119,"collaborators":121,"id":123,"slug":124,"hasResults":125,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":10,"eligibilityCriteria":129,"healthyVolunteers":125,"sex":130,"minAge":131,"maxAge":10,"enrollmentInfo":132,"targetDuration":10,"studyType":135,"phases":10,"briefSummary":136,"conditions":137,"keywords":10,"overallStatus":139,"whyStopped":10,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"fullName":5,"class":6},"Shanghai Zhongshan Hospital","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A",null,"Donafenib +PD-1\u002FL1+TACE",[13,14,15],"Drug: Donafeinib","Procedure: Transcatheter arterial chemoembolization","Drug: PD-1 \u002F PD-L1 monoclonal antibody",{"label":17,"type":10,"description":18,"interventionNames":19},"GROUP B","Donafenib +PD-1\u002FL1+HAIC",[13,15,20],"Procedure: Hepatic Artery Infusion Chemotherapy",[22,27,32,36],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":10},"DRUG","Donafeinib","Donafenib: 200mg Bid, or follow medical order",[17,9],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":10},"PROCEDURE","Transcatheter arterial chemoembolization","Follow medical order",[9],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":10},"PD-1 \u002F PD-L1 monoclonal antibody","Follow Drug instructions or medical order",[17,9],{"type":28,"name":37,"description":38,"armGroupLabels":39,"otherNames":10},"Hepatic Artery Infusion Chemotherapy","Follow medical orders",[17],[41],{"name":42,"role":43,"phone":44,"phoneExt":10,"email":45},"Zheng Wang","CONTACT","+86 021 6404 1990","wang.zheng@zs-hospital.sh.cn",[47,59,64,69,78,92,101,110],{"facility":48,"status":10,"city":49,"state":50,"zip":10,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":10},"Sun Yat-sen Memorial Hospital","Guangzhou","Guangdong","China","CN",{"type":54,"coordinates":55},"Point",[56,57],113.25,23.11667,{"lat":57,"lon":56},{"facility":60,"status":10,"city":49,"state":50,"zip":10,"country":51,"countryCode":52,"cosmosGeoPoint":61,"geoPoint":63,"contacts":10},"Sun Yat-sen University Cancer Center",{"type":54,"coordinates":62},[56,57],{"lat":57,"lon":56},{"facility":65,"status":10,"city":49,"state":50,"zip":10,"country":51,"countryCode":52,"cosmosGeoPoint":66,"geoPoint":68,"contacts":10},"Zhujiang Hospital of Southern Medical University",{"type":54,"coordinates":67},[56,57],{"lat":57,"lon":56},{"facility":70,"status":10,"city":71,"state":72,"zip":10,"country":51,"countryCode":52,"cosmosGeoPoint":73,"geoPoint":77,"contacts":10},"The First Affiliated Hospital of Guangxi Medical University","Nanning","Guangxi",{"type":54,"coordinates":74},[75,76],108.31667,22.81667,{"lat":76,"lon":75},{"facility":79,"status":10,"city":80,"state":81,"zip":10,"country":51,"countryCode":52,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Harbin Medical University Cancer Hospital","Harbin","Heilongjiang",{"type":54,"coordinates":83},[84,85],126.65,45.75,{"lat":85,"lon":84},[88],{"name":89,"role":43,"phone":90,"phoneExt":10,"email":91},"Yingchen Li","+86 0451 8629 8666","xiakanfanxing@163.com",{"facility":93,"status":10,"city":94,"state":95,"zip":10,"country":51,"countryCode":52,"cosmosGeoPoint":96,"geoPoint":100,"contacts":10},"The Affiliated Hospital of Qingdao University","Qingdao","Shandong",{"type":54,"coordinates":97},[98,99],120.38042,36.06488,{"lat":99,"lon":98},{"facility":102,"status":10,"city":103,"state":104,"zip":10,"country":51,"countryCode":52,"cosmosGeoPoint":105,"geoPoint":109,"contacts":10},"Zhong Shan Hospital Fudan University","Shanghai","Shanghai Municipality",{"type":54,"coordinates":106},[107,108],121.45806,31.22222,{"lat":108,"lon":107},{"facility":111,"status":10,"city":112,"state":113,"zip":10,"country":51,"countryCode":52,"cosmosGeoPoint":114,"geoPoint":118,"contacts":10},"Yunnan Cancer Hospital","Kunming","Yunan",{"type":54,"coordinates":115},[116,117],102.71833,25.03889,{"lat":117,"lon":116},{"type":120,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[122],{"name":111,"class":6},"100648744","the-efficacy-and-safety-of-donafenib-plus-pd-1l1-monoclonal-antibodies-plus-tace-or-haic-as-first-line-treatment-for-unresectable-hepatocellular-carcinoma-a-multi-center-retrospective-clinical-study-100648744",false,"NCT07724951","The Efficacy and Safety of Donafenib Plus PD-1\u002FL1 Monoclonal Antibodies Plus TACE or HAIC as First-line Treatment for Unresectable Hepatocellular Carcinoma A Multi-center, Retrospective Clinical Study","The Efficacy and Safety of Donafenib Plus PD-1\u002FL1 Monoclonal Antibodies Plus Transarterial Chemoembolization (TACE) or Hepatic Arterial Infusion Chemotherapy (HAIC) as First-line Treatment for Unresectable Hepatocellular carcinomaA Multicenter, Retrospective Clinical Study","Inclusion Criteria:\n\n* Patients with unresectable hepatocellular carcinoma (uHCC) who received donafenib, an anti-PD-1\u002FL1 monoclonal antibody combined with transarterial interventional therapy (TACE or HAIC), with retrievable records in the hospital electronic information system between June 1, 2021 and November 30, 2024.\n* Diagnosis of hepatocellular carcinoma confirmed by the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2024 Edition) clinically or by histology\u002Fcytology.\n* Age ≥18 years, regardless of sex.\n* No prior systemic therapy before the administration of donafenib, anti-PD-1\u002FL1 monoclonal antibody combined with transarterial interventional therapy (TACE or HAIC).\n* The maximum interval between the initiation of donafenib, anti-PD-1\u002FL1 monoclonal antibody, and transarterial interventional therapy (TACE or HAIC) does not exceed 8 weeks, and at the time the last of these treatment modalities is initiated, the subject must not have experienced disease progression.\n* For patients who have previously undergone hepatectomy, the resection must be R0, and tumor recurrence must have occurred more than 24 months after surgery.\n* At least one evaluable lesion (according to RECIST v1.1 criteria).\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 to 1.\n* Child-Pugh class A or B.\n* Adequate major organ function, defined by the following criteria:\n\nComplete blood count (without blood transfusion or use of granulocyte colony-stimulating factor \\[G-CSF\\] within 14 days prior to screening):\n\n1. Hemoglobin ≥90 g\u002FL;\n2. Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL;\n3. Platelet count ≥75×10⁹\u002FL;\n\n   \\- Blood biochemistry (without albumin use within 14 days prior to screening):\n4. Albumin ≥28 g\u002FL;\n5. Total bilirubin ≤2× upper limit of normal (ULN);\n6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5× ULN;\n7. Alkaline phosphatase (ALP) ≤5× ULN;\n8. Creatinine ≤1.5× ULN;\n\n   \\- Coagulation function:\n9. International normalized ratio (INR) or prothrombin time (PT) ≤1.5× ULN;\n10. Activated partial thromboplastin time (APTT) ≤1.5× ULN.\n\nExclusion Criteria:\n\n* Incomplete or unavailable patient information data; patient refused follow-up or was lost to follow-up;\n* Duration of donafenib, PD-1\u002FL1 monoclonal antibody combined with transarterial intervention therapy was less than 1 month;\n* Prior histologically\u002Fcytologically confirmed diagnosis of fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, or other components;\n* History of malignancy other than hepatocellular carcinoma, unless meeting the following criteria: a) The patient received potentially curative treatment and there has been no evidence of disease for 5 years; b) Successfully treated resected cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or other carcinoma in situ;","ALL","18 Years",{"count":133,"type":134},400,"ESTIMATED","OBSERVATIONAL","This is a multicenter, retrospective study planned to enroll patients with unresectable hepatocellular carcinoma (uHCC) who received first-line donafenib combined with an anti-PD-1\u002FL1 monoclonal antibody and either TACE or HAIC at 8 sites between June 1, 2021 and November 30, 2024. The study consists of two cohorts: Cohort A consists of patients who received donafenib + PD-1\u002FL1 inhibitor + TACE, and Cohort B consists of patients who received donafenib + PD-1\u002FL1 inhibitor + HAIC, with a planned enrollment of 200 patients per cohort. Relevant data will be collected to evaluate the efficacy and safety of donafenib combined with an anti-PD-1\u002FL1 monoclonal antibody and either TACE or HAIC in the treatment of uHCC in real-world clinical practice.",[138],"Hepatocellular Carcinoma (HCC)","NOT_YET_RECRUITING","2026-07-24",{"date":142,"type":143},"2026-07-27","ACTUAL",{"date":145,"type":134},"2026-07-31",{"date":147,"type":134},"2028-07-31",{"name":5,"class":6},8]