EDN Combined With TACE/HAIC and Second-Line Immune-Targeted Treatment Versus TACE/HAIC Alone in L… (NCT07187284) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
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
China62 participantsStarted 2025-09-30
Plain-language 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/HAIC) 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).
The main questions this study aims to answer are:
Does the addition of EDN to standard TACE/HAIC 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/HAIC + immune-targeted therapy) with the control group (TACE/HAIC + 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.
Participants will:
Undergo screening assessments including imaging (CT/MRI), blood tests, and ECG within specified time windows.
Receive assigned interventions (EDN procedure or control) during the baseline visit (Day 0).
Attend 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.
Have their tumor response, survival outcomes, and adverse events monitored throughout the study.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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:
Exclusion criteria
✕. Preoperative abdominal CT or MR enhanced scan suggests celiac trunk anatomy is unsuitable for EDN procedure.
✕. History of orthostatic hypotension.
What they're measuring
1
hPFS
Timeframe: From date of randomization until the date of first documented intrahepatic progression or date of death from any cause, whichever comes first, assessed up to 12 months.