[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635521":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":41,"locations":51,"responsibleParty":95,"collaborators":98,"id":104,"slug":105,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":28,"eligibilityCriteria":110,"healthyVolunteers":106,"sex":111,"minAge":112,"maxAge":113,"enrollmentInfo":114,"targetDuration":28,"studyType":117,"phases":118,"briefSummary":120,"conditions":121,"keywords":125,"overallStatus":130,"whyStopped":28,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},{"fullName":5,"class":6},"Ningbo No.2 Hospital","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Peginterferon alfa-2b combined with NAs","EXPERIMENTAL","Patients receive peginterferon alfa-2b (Pegintron®) combined with first-line nucleos(t)ide analogues (TDF\u002FTAF\u002FTMF)",[13,14,15,16],"Drug: Peginterferon alfa-2b","Drug: TDF","Drug: TAF","Drug: TMF",{"label":18,"type":19,"description":20,"interventionNames":21},"NAs alone","ACTIVE_COMPARATOR","Patients receive first-line nucleos(t)ide analogues (TDF\u002FTAF\u002FTMF) alone",[14,15,16],[23,29,33,37],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Peginterferon alfa-2b","Peginterferon alfa-2b injection administered subcutaneously",[9],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"TDF","Tenofovir disoproxil fumarate",[18,9],{"type":24,"name":34,"description":35,"armGroupLabels":36,"otherNames":28},"TAF","Tenofovir alafenamide",[18,9],{"type":24,"name":38,"description":39,"armGroupLabels":40,"otherNames":28},"TMF","Tenofovir amibufenamide",[18,9],[42,47],{"name":43,"role":44,"phone":45,"phoneExt":28,"email":46},"Liyun Fu","CONTACT","+86 13777966906","nbfly2009@126.com",{"name":48,"role":44,"phone":49,"phoneExt":28,"email":50},"Mengyuan Hu","+86 17858767819","hmy_helen@163.com",[52,68,80,88],{"facility":53,"status":28,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Shulan (Hangzhou) Hospital","Hangzhou","Zhejiang","310022","China","CN",{"type":60,"coordinates":61},"Point",[62,63],120.16142,30.29365,{"lat":63,"lon":62},[66,67],{"name":43,"role":44,"phone":45,"phoneExt":28,"email":46},{"name":48,"role":44,"phone":49,"phoneExt":28,"email":50},{"facility":69,"status":28,"city":70,"state":55,"zip":71,"country":57,"countryCode":58,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Ningbo Medical Center Lihuili Hospital","Ningbo","315000",{"type":60,"coordinates":73},[74,75],121.54945,29.87819,{"lat":75,"lon":74},[78,79],{"name":43,"role":44,"phone":45,"phoneExt":28,"email":46},{"name":48,"role":44,"phone":49,"phoneExt":28,"email":50},{"facility":81,"status":28,"city":70,"state":55,"zip":71,"country":57,"countryCode":58,"cosmosGeoPoint":82,"geoPoint":84,"contacts":85},"Ningbo Mingzhou Hospital (Affiliated to Zhejiang University)",{"type":60,"coordinates":83},[74,75],{"lat":75,"lon":74},[86,87],{"name":43,"role":44,"phone":45,"phoneExt":28,"email":46},{"name":48,"role":44,"phone":49,"phoneExt":28,"email":50},{"facility":5,"status":28,"city":70,"state":55,"zip":71,"country":57,"countryCode":58,"cosmosGeoPoint":89,"geoPoint":91,"contacts":92},{"type":60,"coordinates":90},[74,75],{"lat":75,"lon":74},[93,94],{"name":43,"role":44,"phone":45,"phoneExt":28,"email":46},{"name":48,"role":44,"phone":49,"phoneExt":28,"email":50},{"type":96,"investigatorFullName":43,"investigatorTitle":97,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"PRINCIPAL_INVESTIGATOR","Chief Physician",[99,101,103],{"name":69,"class":100},"OTHER_GOV",{"name":81,"class":102},"UNKNOWN",{"name":53,"class":6},"100635521","early-phase-1-efficacy-and-safety-of-pegylated-interferon-alpha-2-in-patients-with-hepatitis-b-related-hepatocellular-carcinoma-after-radical-resection-100635521",false,"NCT07553767","Efficacy and Safety of Pegylated Interferon Alpha-2β in Patients With Hepatitis B-related Hepatocellular Carcinoma After Radical Resection","A Non-randomized Controlled, Prospective, Real-world Study to Evaluate the Efficacy and Safety of Pegylated Interferon Alpha-2β in Patients With Hepatitis B-related Hepatocellular Carcinoma After Radical Resection","Inclusion Criteria:\n\n* Age 18 to 65 years, male or female.\n* Confirmed diagnosis of hepatitis B virus-related hepatocellular carcinoma (HCC) by pathology or contrast-enhanced CT\u002FMRI.\n* Underwent radical resection or local ablation therapy; CNLC (Chinese Liver Cancer Classification) stage Ia, Ib, or IIa; no residual tumor confirmed by imaging within 1-3 months postoperation.\n* HBsAg positive and HBsAg level \\\u003C 2000 IU\u002FmL.\n* No prior systemic chemotherapy, immunotherapy, or targeted therapy before enrollment.\n* Able to provide written informed consent and comply with the follow-up schedule.\n* For women of childbearing potential: negative pregnancy test and effective contraception during treatment and for 24 weeks after the last dose.\n\nExclusion Criteria:\n\n* Recurrent or metastatic HCC at enrollment.\n* Contraindication to peginterferon alfa-2b treatment.\n* WBC \\\u003C 3.5×10⁹\u002FL or platelet count \\\u003C 100×10⁹\u002FL.\n* ALT \\> 3×ULN or total bilirubin (TBIL) \\> 2×ULN.\n* Child-Pugh score \\> 5 points.\n* INR \\> 1.5.\n* History of organ transplantation or planned transplantation.\n* Hypersensitivity to peginterferon alfa-2b or any excipient of the study drug.\n* Pregnant or breastfeeding women.\n* Participation in another interventional clinical trial.\n* History of significant alcoholism or drug abuse.\n* Genetic or metabolic liver disease (Wilson disease, hemochromatosis, etc.).\n* Coinfection with HAV, HCV, HEV, EBV, CMV , or other viral hepatitis that may interfere with study evaluation.\n* Unable to comply with study procedures and follow-up.\n* Other conditions deemed inappropriate by the investigator.","ALL","18 Years","65 Years",{"count":115,"type":116},156,"ESTIMATED","INTERVENTIONAL",[119],"EARLY_PHASE1","The goal of this clinical trial is to evaluate the efficacy and safety of peginterferon alfa-2β (Peg-IFN-α-2β) combined with nucleos(t)ide analogues (NAs) in patients aged 18 to 65 years with hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC) after radical resection. The main questions it aims to answer are:\n\n* What are the changes in hepatitis B surface antigen (HBsAg) disappearance rate, HBsAg seroconversion rate, HBsAg decline, and hepatitis B virus deoxyribonucleic acid (HBV DNA) levels during treatment and at the end of treatment?\n* What are the 1-year, 2-year, 3-year, and 5-year recurrence-free survival (RFS) and overall survival (OS) of the included patients?\n* What are the correlations between changes in HBsAg, T helper 1\u002FT helper 2 (Th1\u002FTh2) subsets, intestinal flora and RFS, OS in these patients?\n\nResearchers will compare Peg-IFN-α-2β combined with NAs to NAs alone to see if the combination treatment can improve HBsAg clearance, seroconversion, long-term survival and reduce recurrence in patients after radical resection of hepatitis B-related hepatocellular carcinoma.\n\nParticipants will:\n\n* Receive either Peg-IFN-α-2β combined with first-line NAs (tenofovir disoproxil fumarate \\[TDF\\], tenofovir alafenamide fumarate \\[TAF\\], tenofovir amibufen fumarate \\[TMF\\]) or first-line NAs alone\n* Undergo regular assessments including HBsAg, HBV DNA, liver and renal function, blood routine, thyroid function, autoantibodies, and tumor markers\n* Provide stool samples for intestinal flora analysis at specified time points\n* Complete long-term survival follow-up for up to 5 years",[122,123,124],"Hepatocellular Carcinoma","HEPATITIS B CHRONIC","Hepatitis B Chronic Infection",[126,127,128,129],"Peg-IFN-α-2b","hepatitis B","hepatocellular carcinoma","prognosis","NOT_YET_RECRUITING","2026-04-20",{"date":133,"type":134},"2026-04-28","ACTUAL",{"date":136,"type":116},"2026-03-31",{"date":138,"type":116},"2035-12-31",{"name":5,"class":6},4]