Status:
NOT_YET_RECRUITING
EDN Combined With TACE/HAIC and Second-Line Immune-Targeted Treatment Versus TACE/HAIC Alone in Locally Advanced HCC With Portal Vein Tumor Thrombosis After First-Line Therapy Failure: A Prospective, Multicenter, Randomized Controlled Trial
Lead Sponsor:
Zhongda Hospital
Conditions:
HCC - Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
The goal of this clinical trial is to evaluate the efficacy and safety of combining endovascular denervation (EDN) with transarterial chemoembolization/ hepatic arterial infusion chemotherapy (TACE/HA...
Eligibility Criteria
Inclusion
- Aged 18 to 75 years (inclusive), regardless of gender.
- Diagnosis of CNLC Stage IIIa HCC with portal vein tumor thrombus (vp type 1-3) confirmed by histopathology, cytology, or imaging.
- Progression of disease after first-line systemic therapy.
- At least one measurable lesion according to RECIST 1.1 criteria.
- Child-Pugh class A or B.
- ECOG performance status of 0 to 2.
- Scheduled to undergo TACE or HAIC treatment.
- Adequate hematological, hepatic, and renal function within 14 days prior to study initiation, defined as:
- White blood cell count ≥2.0×10⁹/L AND neutrophil count ≥1.0×10⁹/L. Platelet count ≥60×10⁹/L. Hemoglobin concentration ≥90 g/L. Total bilirubin ≤2.0 × upper limit of normal (ULN). Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5 × ULN. Albumin ≥2.8 g/dL. International normalized ratio (INR) ≤1.6. Creatinine ≤1.5 × ULN AND calculated creatinine clearance ≥30 mL/min.
Exclusion
- Preoperative abdominal CT or MR enhanced scan suggests celiac trunk anatomy is unsuitable for EDN procedure.
- History of orthostatic hypotension.
- Diffuse liver tumors or extensive extrahepatic metastases with an expected survival of \<3 months.
- Cachexia or multi-organ failure.
- Severe hepatic dysfunction (Child-Pugh class C).
- Uncorrectable coagulation dysfunction.
- Presence of severe concurrent infection.
- Accompanied by Vp4 type portal vein tumor thrombus.
- Abnormal blood supply to the target lesion that precludes transarterial interventional therapy.
- History of bilioenteric anastomosis within the past year.
- Severe allergy to known contrast agents or embolization materials.
- Pregnant or lactating women, or individuals with childbearing potential planning pregnancy during the trial period.
- Clinically significant (e.g., active) cardiovascular disease, including:
- 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.
- ≥Grade 3 peripheral vascular disease (e.g., symptomatic and interfering with activities of daily living, requiring intervention).
- Transient ischemic attack or subarachnoid hemorrhage within 6 months prior to randomization, or participation in other drug or device clinical trials within 3 months.
- History of other malignancies within the past 5 years or concurrent other malignancies.
- Any other condition deemed by the investigator as unsuitable for participation in this study.
Key Trial Info
Start Date :
September 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT07187284
Start Date
September 30 2025
End Date
September 30 2027
Last Update
September 22 2025
Active Locations (1)
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1
Zhongda Hospital Affiliated to Southeast University, Department of Interventional and Vascular Surgery
Nanjing, Jiangsu, China, 210009