[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619915":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":51,"collaborators":26,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":26,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":26,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":26,"overallStatus":76,"whyStopped":26,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Tongji Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Postoperative active monitoring cohort","ACTIVE_COMPARATOR","The postoperative active monitoring cohort collected a single blood sample for MRD monitoring before the surgery, and then dynamically collected blood samples for MRD monitoring at each follow-up visit after the surgery. This cohort only received active monitoring after the surgery.",[13],"Other: Active monitoring",{"label":15,"type":16,"description":17,"interventionNames":18},"Postoperative PD-1 inhibitor adjuvant therapy cohort","EXPERIMENTAL","The postoperative PD-1 inhibitor-adjuvant cohort collected one blood sample for MRD monitoring before surgery, and dynamically collected blood samples for MRD monitoring at each follow-up visit after surgery. This cohort received only regular PD-1 inhibitor-assisted treatment after surgery.",[19],"Drug: Adjuvant PD-1 inhibitors",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Adjuvant PD-1 inhibitors","The patients in the postoperative adjuvant treatment cohort received regular PD-1 inhibitor adjuvant therapy (Sintilimab), once every 21 days, for a total of 8 times, and undergoing dynamic MRD testing.",[15],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Active monitoring","The patients in the active monitoring cohort only received regular follow-up and MRD testing after the surgery.",[9],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Wanguang Zhang","CONTACT","13886195965","wgzhang@tjh.tjmu.edu.cn",[38],{"facility":39,"status":26,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":26},"Division of Hepato-Pancreato-Biliary Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology","Wuhan","Hubei","430000","China","CN",{"type":46,"coordinates":47},"Point",[48,49],114.26667,30.58333,{"lat":49,"lon":48},{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Wan-Guang Zhang","Professor","100619915","predictive-value-of-minimal-residual-disease-for-postoperative-recurrence-and-adjuvant-pd-1-inhibitor-in-hcc-100619915",false,"NCT07350824","Predictive Value of Minimal Residual Disease for Postoperative Recurrence and Adjuvant PD-1 Inhibitor in HCC","Predictive Value of Minimal Residual Disease for Postoperative Recurrence and Adjuvant PD-1 Inhibitor in Hepatocellular Carcinoma: A Prospective, Multicenter Study","Inclusion Criteria:\n\n* Age between 18 and 75 years, inclusive, regardless of gender.\n* Newly diagnosed, treatment-naïve patients with HCC.\n* Received radical treatments, such as liver resection or microwave ablation.\n* Combine at least one of the risk factors for tumor recurrence, such as microvascular\u002Fmacrovascular invasion, poor differentiation, satellite nodules, multiple tumors, and tumor diameter greater than 5 cm.\n* Child-Pugh liver function score ≤ 7.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Absence of severe organic diseases affecting the heart, lungs, brain, or other major organs.\n\nExclusion Criteria:\n\n* History of other malignancies.\n* Recurrent HCC.\n* Prior systemic therapy for HCC.\n* Unable to complete the follow-up and dynamic MRD monitoring.\n* Having an immune deficiency disorder.\n* Allergic to PD-1 inhibitors or unable to tolerate related treatments.","ALL","18 Years","75 Years",{"count":66,"type":67},276,"ESTIMATED","INTERVENTIONAL",[70],"NA","Hepatocellular carcinoma (HCC) is a leading global cause of cancer-related mortality. While curative resection is pivotal, high postoperative recurrence rates remain a major challenge. Adjuvant immune checkpoint inhibitors (ICIs) show promise in improving outcomes, but biomarkers to identify patients who will benefit are lacking. Current clinicopathological risk factors for minimal residual disease (MRD) are suboptimal in sensitivity and specificity.\n\nCirculating tumor DNA (ctDNA) analysis, reflecting real-time tumor dynamics, offers a promising approach for MRD detection. This study focuses on the methylation status of GNB4 and Riplet-genes located within HCC-associated CpG islands-using a bespoke bisulfite-conversion and qPCR assay to sensitively detect methylated alleles, thereby enabling MRD monitoring.\n\nTo clinically validate this approach, we will conduct a prospective, multicenter cohort study assessing the predictive value of serial \\*GNB4\u002FRiplet\\* methylation testing for recurrence and adjuvant therapy benefit.",[73,74,75],"HCC","Minimal Residual Disease","Recurrence","NOT_YET_RECRUITING","2026-01-09",{"date":79,"type":80},"2026-01-20","ACTUAL",{"date":82,"type":67},"2025-12-31",{"date":84,"type":67},"2028-12-31",{"name":5,"class":6},1]