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

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

62

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2027

Conditions
HCC - Hepatocellular Carcinoma
Interventions
COMBINATION_PRODUCT

EDN combined with TACE/HAIC and Immuno-Targeted Therapy

"Experimental Intervention (Treatment Group):~This 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:~Endovascular Denervation (EDN): A one-time, catheter-based percutaneous procedure for the ablation of peri-arterial sympathetic nerves surrounding the common hepatic artery and/or 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.~On-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."

COMBINATION_PRODUCT

TACE/HAIC 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.

Trial Locations (1)

210009

Zhongda Hospital Affiliated to Southeast University, Department of Interventional and Vascular Surgery, Nanjing

All Listed Sponsors
lead

Zhongda Hospital

OTHER

NCT07187284 - 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 | Biotech Hunter | Biotech Hunter