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.
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.
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.