[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607340":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":54,"collaborators":26,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":26,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":26,"studyType":71,"phases":72,"briefSummary":75,"conditions":76,"keywords":26,"overallStatus":78,"whyStopped":26,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Zhongda Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment intervention group","EXPERIMENTAL","Participants randomized to the treatment intervention group will receive the following combination therapy: 1.A single procedure of Endovascular Denervation (EDN): Percutaneous catheter-based ablation of the peri-arterial sympathetic nerves. 2.On-demand Transarterial Interventional Therapy: This consists of either Transarterial Chemoembolization (TACE) or Hepatic Arterial Infusion Chemotherapy (HAIC), administered based on individual patient's disease assessment and treatment response. 3.Second-line Immuno-Targeted Drug Therapy: Standard systemic therapy with a combination of immune checkpoint inhibitors and targeted agents (e.g., anti-PD-1\u002FPD-L1 antibodies plus tyrosine kinase inhibitors or VEGF inhibitors). The specific drugs are not limited by the protocol and are chosen at the investigator's discretion according to local standards of care.",[13],"Combination Product: EDN combined with TACE\u002FHAIC and Immuno-Targeted Therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","ACTIVE_COMPARATOR","Participants randomized to the control group will receive the current standard of care for the studied patient population, which consists of:\n\n1. On-demand Transarterial Interventional Therapy: This consists of either Transarterial Chemoembolization (TACE) or Hepatic Arterial Infusion Chemotherapy (HAIC), administered based on individual patient's disease assessment and treatment response.\n2. Second-line Immuno-Targeted Drug Therapy: Standard systemic therapy with a combination of immune checkpoint inhibitors and targeted agents (e.g., anti-PD-1\u002FPD-L1 antibodies plus tyrosine kinase inhibitors or VEGF inhibitors). The specific drugs are not limited by the protocol and are chosen at the investigator's discretion according to local standards of care.",[19],"Combination Product: TACE\u002FHAIC plus Immuno-Targeted Therapy",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"COMBINATION_PRODUCT","EDN combined with TACE\u002FHAIC and Immuno-Targeted Therapy","Experimental Intervention (Treatment Group):\n\nThis arm evaluates a novel combination strategy. Participants will undergo a single session of Endovascular Denervation (EDN) in conjunction with standard care. The complete intervention includes:\n\nEndovascular Denervation (EDN): A one-time, catheter-based percutaneous procedure for the ablation of peri-arterial sympathetic nerves surrounding the common hepatic artery and\u002For proper hepatic artery. The procedure utilizes a multi-electrode radiofrequency ablation system (e.g., Netrod®). Ablation parameters are set to 60°C for 120 seconds per site, with a minimum of 20 ablations performed to ensure adequate denervation.\n\nOn-demand Transarterial Intervention: Following EDN, participants will receive either Transarterial Chemoembolization (TACE) or Hepatic Arterial Infusion Chemotherapy (HAIC), as determined by the treating investigator based on individual patient anatomy and tumor characteristics.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"TACE\u002FHAIC plus Immuno-Targeted Therapy","This is the active comparator intervention representing the current standard-of-care regimen for the study population. Participants randomized to the control group will receive a combination of locoregional and systemic therapy, specifically excluding the experimental Endovascular Denervation (EDN) procedure.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Tao Pan","CONTACT","+8615850651223","15850651223@126.com",[38],{"facility":39,"status":26,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Zhongda Hospital Affiliated to Southeast University, Department of Interventional and Vascular Surgery","Nanjing","Jiangsu","210009","China","CN",{"type":46,"coordinates":47},"Point",[48,49],118.77778,32.06167,{"lat":49,"lon":48},[52],{"name":53,"role":34,"phone":35,"phoneExt":26,"email":36},"Pan",{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Gao-jun Teng","Dr. Teng was elected as an Academician of the Chinese Academy of Sciences in 2021 and as a Fellow of the Chinese Academy of Medical Sciences in 2022.","100607340","phase-1-edn-combined-with-tacehaic-and-second-line-immune-targeted-treatment-versus-tacehaic-alone-in-locally-advanced-hcc-with-portal-vein-tumor-thrombosis-after-first-line-therapy-failure-a-prospective-multicenter-randomized-controlled-trial-100607340",false,"NCT07187284","EDN Combined With TACE\u002FHAIC and Second-Line Immune-Targeted Treatment Versus TACE\u002FHAIC Alone in Locally Advanced HCC With Portal Vein Tumor Thrombosis After First-Line Therapy Failure: A Prospective, Multicenter, Randomized Controlled Trial","Evaluating Endervascular Denervation (EDN) Combined With Transarterial Intervention (TACE\u002FHAIC) and Second-Line Immune-Targeted Therapy in Locally Advanced Hepatocellular Carcinoma (HCC) With Portal Vein Tumor Thrombosis After Progression on First-Line Systemic Therapy: A Prospective, Multicenter, Randomized Controlled Study","Inclusion Criteria:\n\n1. Aged 18 to 75 years (inclusive), regardless of gender.\n2. Diagnosis of CNLC Stage IIIa HCC with portal vein tumor thrombus (vp type 1-3) confirmed by histopathology, cytology, or imaging.\n3. Progression of disease after first-line systemic therapy.\n4. At least one measurable lesion according to RECIST 1.1 criteria.\n5. Child-Pugh class A or B.\n6. ECOG performance status of 0 to 2.\n7. Scheduled to undergo TACE or HAIC treatment.\n8. Adequate hematological, hepatic, and renal function within 14 days prior to study initiation, defined as:\n\nWhite blood cell count ≥2.0×10⁹\u002FL AND neutrophil count ≥1.0×10⁹\u002FL. Platelet count ≥60×10⁹\u002FL. Hemoglobin concentration ≥90 g\u002FL. Total bilirubin ≤2.0 × upper limit of normal (ULN). Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5 × ULN. Albumin ≥2.8 g\u002FdL. International normalized ratio (INR) ≤1.6. Creatinine ≤1.5 × ULN AND calculated creatinine clearance ≥30 mL\u002Fmin.\n\nExclusion Criteria:\n\n1. Preoperative abdominal CT or MR enhanced scan suggests celiac trunk anatomy is unsuitable for EDN procedure.\n2. History of orthostatic hypotension.\n3. Diffuse liver tumors or extensive extrahepatic metastases with an expected survival of \\\u003C3 months.\n4. Cachexia or multi-organ failure.\n5. Severe hepatic dysfunction (Child-Pugh class C).\n6. Uncorrectable coagulation dysfunction.\n7. Presence of severe concurrent infection.\n8. Accompanied by Vp4 type portal vein tumor thrombus.\n9. Abnormal blood supply to the target lesion that precludes transarterial interventional therapy.\n10. History of bilioenteric anastomosis within the past year.\n11. Severe allergy to known contrast agents or embolization materials.\n12. Pregnant or lactating women, or individuals with childbearing potential planning pregnancy during the trial period.\n13. Clinically significant (e.g., active) cardiovascular disease, including:\n\n    Unstable angina within ≤6 months prior to randomization. New York Heart Association (NYHA) class ≥II congestive heart failure. Poorly controlled arrhythmia despite medication (patients with controlled atrial fibrillation are eligible), or any clinically significant abnormality found on resting ECG.\n\n    ≥Grade 3 peripheral vascular disease (e.g., symptomatic and interfering with activities of daily living, requiring intervention).\n\n    Transient ischemic attack or subarachnoid hemorrhage within 6 months prior to randomization, or participation in other drug or device clinical trials within 3 months.\n14. History of other malignancies within the past 5 years or concurrent other malignancies.\n15. Any other condition deemed by the investigator as unsuitable for participation in this study.","ALL","18 Years","75 Years",{"count":69,"type":70},62,"ESTIMATED","INTERVENTIONAL",[73,74],"PHASE1","PHASE2","The goal of this clinical trial is to evaluate the efficacy and safety of combining endovascular denervation (EDN) with transarterial chemoembolization\u002F hepatic arterial infusion chemotherapy (TACE\u002FHAIC) plus second-line immune-targeted therapy in patients with locally advanced hepatocellular carcinoma (HCC) who have progressed after first-line systemic therapy and present with portal vein tumor thrombus (PVTT).\n\nThe main questions this study aims to answer are:\n\nDoes the addition of EDN to standard TACE\u002FHAIC and immune-targeted therapy improve intrahepatic progression-free survival (hPFS) based on RECIST 1.1 criteria? What is the safety profile of the combined treatment, including device-related adverse events? Researchers will compare the experimental group (EDN + TACE\u002FHAIC + immune-targeted therapy) with the control group (TACE\u002FHAIC + immune-targeted therapy alone) in a 1:1 randomized design. A total of 62 participants will be enrolled across 8 centers, with an expected enrollment period of 12 months and a 12-month follow-up period.\n\nParticipants will:\n\nUndergo screening assessments including imaging (CT\u002FMRI), blood tests, and ECG within specified time windows.\n\nReceive assigned interventions (EDN procedure or control) during the baseline visit (Day 0).\n\nAttend follow-up visits at 1 month (±7 days), 3 months (±14 days), 6 months (±30 days), 9 months (±30 days), and 12 months (±30 days) for repeated imaging, laboratory tests, and safety evaluations.\n\nHave their tumor response, survival outcomes, and adverse events monitored throughout the study.",[77],"HCC - Hepatocellular Carcinoma","NOT_YET_RECRUITING","2025-09-19",{"date":81,"type":82},"2025-09-22","ACTUAL",{"date":84,"type":70},"2025-09-30",{"date":86,"type":70},"2027-09-30",{"name":5,"class":6},1]