[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604252":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":10,"centralContacts":50,"locations":56,"responsibleParty":75,"collaborators":10,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":81,"sex":87,"minAge":88,"maxAge":10,"enrollmentInfo":89,"targetDuration":10,"studyType":92,"phases":10,"briefSummary":93,"conditions":94,"keywords":10,"overallStatus":59,"whyStopped":10,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Fudan University","OTHER",[8,14,19],{"label":9,"type":10,"description":10,"interventionNames":11},"HCC cohort 1: Sintilimab plus bevacizumab biosimilar",null,[12,13],"Drug: Sintilimab","Drug: Bevacizumab Biosimilar",{"label":15,"type":10,"description":10,"interventionNames":16},"HCC cohort 2: Camrelizumab plus Rivoceranib",[17,18],"Drug: Camrelizumab","Drug: Rivoceranib",{"label":20,"type":10,"description":10,"interventionNames":21},"HCC cohort 3: O+Y",[22,23],"Drug: Nivolumab","Drug: Ipilimumab",[25,30,34,38,42,46],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":10},"DRUG","Sintilimab","Sintilimab will be administered by IV, 200 mg every 3 weeks",[9],{"type":26,"name":31,"description":32,"armGroupLabels":33,"otherNames":10},"Bevacizumab Biosimilar","Bevacizumab biosimilar will be administered by IV, 15 mg\u002Fkg every 3 weeks.",[9],{"type":26,"name":35,"description":36,"armGroupLabels":37,"otherNames":10},"Camrelizumab","Camrelizumab will be administered by IV, 200 mg every 2 weeks.",[15],{"type":26,"name":39,"description":40,"armGroupLabels":41,"otherNames":10},"Rivoceranib","Rivoceranib will be administered by oral 250 mg once daily.",[15],{"type":26,"name":43,"description":44,"armGroupLabels":45,"otherNames":10},"Nivolumab","Nivolumab will be administered by IV, 1 mg\u002Fkg every 3 weeks for up to four doses, followed by nivolumab 480 mg every 4 weeks",[20],{"type":26,"name":47,"description":48,"armGroupLabels":49,"otherNames":10},"Ipilimumab","Ipilimumab will be administered by IV, 3mg\u002Fkg every 3 weeks for up to four doses.",[20],[51],{"name":52,"role":53,"phone":54,"phoneExt":10,"email":55},"Peng Wang, MD","CONTACT","86-21-64041990","peng_wang@fudan.edu.cn",[57],{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Zhongshan Hospital, Fudan University","RECRUITING","Shanghai","Shanghai Municipality","200032","China","CN",{"type":66,"coordinates":67},"Point",[68,69],121.45806,31.22222,{"lat":69,"lon":68},[72],{"name":73,"role":53,"phone":74,"phoneExt":10,"email":55},"Peng MD, Wang","+86021-64041990",{"type":76,"investigatorFullName":77,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Peng Wang","professor","100604252","different-first-line-immunotherapy-for-advancer-hepatocellular-carcinoma-a-prospective-observational-study-on-efficacy-and-immune-microenvironment-100604252",false,"NCT07147101","Different First-line Immunotherapy for Advancer Hepatocellular Carcinoma: A Prospective Observational Study on Efficacy and Immune Microenvironment","A Prospective, Non-interventional Study of Different First-line Immunotherapy in Advanced Hepatocellular Carcinoma Patients: Efficacy and Immune Microenvironment Dynamics","HCC-IM-1","Inclusion Criteria:\n\n* Age ≥ 18 years at time of study entry.\n* Barcelona Clinic Liver Cancer stage C, or stage B not amenable to curative or locoregional therapies.\n* HCC confirmed by radiology, histology or cytology.\n* No prior systemic therapy for HCC.\n* At least one measurable site of disease as defined by RECIST1.1criteria with spiral CT scan or MRI.\n* Child-Pugh scores 5-7, performance status (PS) ≤ 2 (ECOG scale).\n* Adequate organ function:\n\n  * ANC ≥1.5 × 10⁹\u002FL, platelets ≥100 × 10⁹\u002FL, hemoglobin ≥9 g\u002FdL.\n  * Total bilirubin ≤1.5 × ULN, AST\u002FALT ≤3 × ULN (≤5 × ULN if liver metastases).\n  * Creatinine ≤1.5 × ULN or CrCl ≥60 mL\u002Fmin.\n* Willing to provide archival\u002Ffresh tumor tissue and peripheral blood samples.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Prior systemic therapy for HCC\n* Active autoimmune disease requiring immunosuppression.\n* Active infection requiring IV antibiotics.\n* HIV-positive or active HBV\u002FHCV infection (HBsAg+ with HBV DNA ≥2000 IU\u002FmL; HCV RNA+).\n* Symptomatic CNS metastases.\n* Pregnancy\u002Flactation.\n* Any condition compromising protocol compliance or data interpretation per investigator.","ALL","18 Years",{"count":90,"type":91},150,"ESTIMATED","OBSERVATIONAL","To evaluate the efficacy and immune microenvironment changes in advanced hepatocellular carcinoma (HCC) patients receiving different first-line immunotherapy.",[95],"Advanced Hepatocellular Carcinoma (HCC)","2026-04-18",{"date":98,"type":99},"2026-04-21","ACTUAL",{"date":101,"type":99},"2025-09-01",{"date":103,"type":91},"2028-09-01",{"name":5,"class":6},1]