[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645240":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":16,"studyPopulation":16,"armGroups":34,"interventions":48,"overallOfficials":16,"centralContacts":62,"locations":68,"responsibleParty":89,"collaborators":16,"id":91,"slug":16,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":16,"eligibilityCriteria":96,"healthyVolunteers":92,"sex":97,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":16,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":16,"overallStatus":109,"whyStopped":16,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"Major pathological response (MPR (70%)) rate.","MPR (70%) is defined as residual viable tumor cells \\\u003C= 30% in the tumor bed.","After surgery, approximately 3 months.",[14,18,20,22,25],{"measure":15,"description":16,"timeFrame":17},"Event-free survival (EFS).",null,"From randomization to event, approximately 2 years.",{"measure":19,"description":16,"timeFrame":17},"12-month and 24-month Event-free survival (EFS) rate.",{"measure":21,"description":16,"timeFrame":12},"R0 resection rate.",{"measure":23,"description":16,"timeFrame":24},"Safety endpoints, including adverse events (AEs) and serious adverse events (SAEs) by NCI-CTCAE v6.0.","Approximately 2 years.",{"measure":26,"description":16,"timeFrame":24},"Safety endpoints, including surgical complications by Clavien-Dindo.",{"allocation":28,"interventionModel":29,"interventionModelDescription":30,"primaryPurpose":31,"observationalModel":16,"timePerspective":16,"maskingInfo":32},"RANDOMIZED","PARALLEL","Participants are randomized 1:1 into two cohorts in an open-label, multicenter, phase II perioperative study.","TREATMENT",{"masking":33,"maskingDescription":16,"whoMasked":16},"NONE",[35,43],{"label":36,"type":37,"description":38,"interventionNames":39},"SHR-8068 + Adebrelimab + Apatinib Group","EXPERIMENTAL","SHR-8068, Adebrelimab, Apatinib.",[40,41,42],"Drug: SHR-8068 Injection","Drug: Adebrelimab Injection","Drug: Apatinib Mesylate Tablets",{"label":44,"type":45,"description":46,"interventionNames":47},"Adebrelimab + Apatinib Group","ACTIVE_COMPARATOR","Adebrelimab, Apatinib.",[41,42],[49,54,58],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":16},"DRUG","SHR-8068 Injection","SHR-8068 injection.",[36],{"type":50,"name":55,"description":56,"armGroupLabels":57,"otherNames":16},"Adebrelimab Injection","Adebrelimab injection.",[44,36],{"type":50,"name":59,"description":60,"armGroupLabels":61,"otherNames":16},"Apatinib Mesylate Tablets","Apatinib mesylate tablets.",[44,36],[63],{"name":64,"role":65,"phone":66,"phoneExt":16,"email":67},"Xin Shi","CONTACT","+86-0518-82342973","xin.shi.xs3@hengrui.com",[69],{"facility":70,"status":16,"city":71,"state":72,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"Zhongshan Hospital Fudan University","Shanghai","Shanghai Municipality","200032","China","CN",{"type":77,"coordinates":78},"Point",[79,80],121.45806,31.22222,{"lat":80,"lon":79},[83,87],{"name":84,"role":65,"phone":85,"phoneExt":16,"email":86},"Jian Zhou","+86-021-64041990","zhou.jian@zs-hospital.sh.cn",{"name":84,"role":88,"phone":16,"phoneExt":16,"email":16},"PRINCIPAL_INVESTIGATOR",{"type":90,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","100645240",false,"NCT07682272","A Trial of SHR-8068 Combined With Adebrelimab and Apatinib in Perioperative Treatment of Resectable Hepatocellular Carcinoma","A Randomized, Open-label, Multicenter Phase II Study of SHR-8068 Combined With Adebrelimab and Apatinib for Perioperative Treatment in Resectable Hepatocellular Carcinoma With Intermediate or High Recurrence Risk","Inclusion Criteria:\n\n1. Subjects who voluntarily participate in this study and sign the informed consent form.\n2. Age from 18 to 70, male or female.\n3. Histopathologically\u002Fcytologically confirmed or clinically diagnosed with hepatocellular carcinoma (HCC).\n4. At least one measurable lesion based on RECIST v1.1.\n5. No prior systemic antitumor therapy for HCC.\n6. ECOG Performance Status (PS) score of 0-1.\n7. Child-Pugh liver function class A.\n8. Expected survival at least 3 months.\n9. Adequate organ function.\n10. Blood pregnancy negative (women of childbearing age) and non-breastfeeding, effective contraception.\n\nExclusion Criteria:\n\n1. Known intrahepatic cholangiocarcinoma, sarcomatoid hepatocellular carcinoma, mixed hepatocellular carcinoma, or fibrolamellar hepatocellular carcinoma.\n2. Other malignancies within the past 5 years or concurrent malignancy.\n3. Known history of severe hypersensitivity reaction to any monoclonal antibody.\n4. Previous or current central nervous system metastases.\n5. Clinically symptomatic moderate or severe ascites requiring therapeutic paracentesis or drainage.\n6. Hypertension that cannot be well controlled with antihypertensive medication.\n7. Poorly controlled cardiac symptoms or heart disease.\n8. Known hereditary or acquired bleeding disorders (e.g., coagulopathy) or thrombotic tendency.\n9. Arterial thrombotic or embolic events within 6 months before enrollment.\n10. Any other condition that, in the investigator's judgment, may affect the study results or lead to premature termination of the study.","ALL","18 Years","70 Years",{"count":101,"type":102},120,"ESTIMATED","INTERVENTIONAL",[105],"PHASE2","This study is conducted to evaluate the efficacy and safety of SHR-8068 combined with Adebrelimab and Apatinib compared with Adebrelimab combined with Apatinib in perioperative treatment of resectable hepatocellular carcinoma with intermediate or high recurrence risk.",[108],"Resectable Hepatocellular Carcinoma With Intermediate or High Recurrence Risk","NOT_YET_RECRUITING","2026-06-26",{"date":112,"type":113},"2026-07-02","ACTUAL",{"date":115,"type":102},"2026-07",{"date":117,"type":102},"2029-07",{"name":5,"class":6},1]