[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657528":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":20,"studyPopulation":29,"armGroups":30,"interventions":35,"overallOfficials":20,"centralContacts":39,"locations":45,"responsibleParty":61,"collaborators":20,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":20,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":20,"enrollmentInfo":72,"targetDuration":75,"studyType":76,"phases":20,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":48,"whyStopped":20,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Tianjin Medical University Cancer Institute and Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":20},[9,13],{"measure":10,"description":11,"timeFrame":12},"treatment response","Correlation\u002Fassociation between tissue or blood biomarker results and imaging\u002Fpathology\u002Flaboratory-based treatment response","1 year",{"measure":14,"description":15,"timeFrame":16},"Association between candidate biomarker expression\u002Flevels and recurrence\u002Fprogression risk","Correlation between biomarker results and recurrence\u002Fprogression events, including PFS\u002FRFS","From baseline to end of follow-up",[18,21,24],{"measure":19,"description":20,"timeFrame":12},"Progression-free survival (PFS)",null,{"measure":22,"description":20,"timeFrame":23},"Overall survival (OS)","2 year",{"measure":25,"description":20,"timeFrame":12},"Dynamic changes in alpha-fetoprotein (AFP)",{"allocation":20,"interventionModel":20,"interventionModelDescription":20,"primaryPurpose":20,"observationalModel":27,"timePerspective":28,"maskingInfo":20},"COHORT","CROSS_SECTIONAL","This study uses a multicenter, non-interventional observational design with both prospective and retrospective data and sample collection. The study does not change the patient's established diagnosis or treatment plan and does not assign investigational drugs or treatment pathways. Clinical data, imaging and pathology information, treatment outcomes, and available biospecimens are collected under a unified protocol at baseline, treatment\u002Fsample recording, efficacy and dynamic monitoring, and outcome\u002Flong-term follow-up",[31],{"label":32,"type":20,"description":20,"interventionNames":33},"No investigational",[34],"Other: No investigational intervention. Participants receive standard clinical care. Clinical data, imaging\u002Fpathology information, and available biospecimens are collected for research.",[36],{"type":6,"name":37,"description":37,"armGroupLabels":38,"otherNames":20},"No investigational intervention. Participants receive standard clinical care. Clinical data, imaging\u002Fpathology information, and available biospecimens are collected for research.",[32],[40],{"name":41,"role":42,"phone":43,"phoneExt":20,"email":44},"Yang Liu, PhD.","CONTACT","02223340123","yang_liu@tmu.edu.cn",[46],{"facility":47,"status":48,"city":49,"state":20,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Tianjin Cancer Hospital","RECRUITING","Tianjin","300202","China","CN",{"type":54,"coordinates":55},"Point",[56,57],117.17667,39.14222,{"lat":57,"lon":56},[60],{"name":41,"role":42,"phone":43,"phoneExt":20,"email":44},{"type":62,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100657528","biomarker-validation-for-treatment-efficacy-and-recurrence-prediction-in-hepatocellular-carcinoma-100657528",false,"NCT07840092","Biomarker Validation for Treatment Efficacy and Recurrence Prediction in Hepatocellular Carcinoma","Clinical Validation Study of Biomarkers for Predicting Treatment Efficacy in Patients With Hepatocellular Carcinoma Based on Prospective and Retrospective Clinical Samples","Inclusion Criteria:\n\n* 1\\. Male or female aged ≥18 years. 2. HCC confirmed by imaging and\u002For pathology according to current Chinese guidelines.\n\n  3\\. Receiving standard antitumor therapy, such as surgery, ablation, TACE, targeted therapy, and\u002For immunotherapy, at participating centers and planned for systematic follow-up.\n\n  4\\. ECOG performance status 0-2; expected survival ≥3 months. 5. Child-Pugh class A or stable B; major organ function basically compensated. 6. Agrees to provide or authorize use of available clinical data, imaging\u002Fpathology information, residual tissue\u002Fwax blocks\u002Fslides from routine care, and\u002For residual blood samples. If additional peripheral blood collection is required, the purpose, volume, risks, sample use, and compensation arrangements will be specified in the informed consent form, and the participant must sign a separate written informed consent.\n\nExclusion Criteria:\n\n* 1\\. Active malignancy at other sites, or history of other malignancy within 5 years, except cured in situ carcinoma and basal cell skin carcinoma.\n\n  2\\. Prior liver transplantation or known immunodeficiency disease. 3. Severe heart, lung, renal, or other major organ dysfunction, or uncontrolled severe infection, unable to tolerate routine antitumor therapy and follow-up.\n\n  4\\. Decompensated liver function, such as obvious refractory ascites or hepatic encephalopathy, or Child-Pugh class C.\n\n  5\\. Pregnant or breastfeeding women, or women planning pregnancy who refuse effective contraception.\n\n  6\\. Severe mental disorders or extremely poor compliance, unable to complete follow-up and specimen collection.\n\n  7\\. Other conditions considered unsuitable for inclusion by the investigator.","ALL","18 Years",{"count":73,"type":74},500,"ESTIMATED","2 Years","OBSERVATIONAL","Observational Model: Cohort Time Perspective: Other (prospective and retrospective data\u002Fsample collection) Primary Purpose: Other (biomarker validation for treatment response and recurrence prediction) Biospecimen Retention: Samples With DNA Biospecimen Description: Residual tissue, wax blocks\u002Fslides, residual puncture\u002Fsurgical materials, and residual blood from routine testing; additional peripheral blood, 5-10 mL per collection, may be collected if needed after separate informed consent.\n\nEnrollment: 500 (anticipated) Study Population: Adult patients with HCC confirmed by imaging and\u002For pathology at participating centers, receiving standard antitumor therapy and planned for systematic follow-up.\n\nSampling Method: Not specified in the protocol.",[79],"Hepatocellular Carcinoma (HCC)",[81],"Hepatocellular carcinoma; biomarker; treatment response; recurrence; prognosis; observational study","2026-09-20",{"date":84,"type":85},"2026-09-24","ACTUAL",{"date":87,"type":74},"2026-10-12",{"date":89,"type":74},"2027-12-31",{"name":5,"class":6},1]