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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

ConditionHCC - Hepatocellular Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhongda Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • EDN combined with TACE/HAIC and Immuno-Targeted Therapy

    Combination product

    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.

  • TACE/HAIC plus Immuno-Targeted Therapy

    Combination product

    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.

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: Treatment intervention groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

hPFS

Intrahepatic Progression-Free Survival (hPFS) assessed by RECIST 1.1

Time frame
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.

Secondary outcomes

1

ORR

Objective Response Rate (ORR) assessed by RECIST 1.1

Time frame
From date of randomization until the first documented objective response (CR or PR), assessed up to 12 months.
2

OS

Overall Survival (OS)

Time frame
From date of randomization until date of death from any cause, assessed up to 12 months.
3

PFS

Progression-Free Survival (PFS) assessed by RECIST 1.1

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.
4

DCR

Disease Control Rate (DCR) assessed by RECIST 1.1

Time frame
From date of randomization until the first documented objective response (CR or PR) or stable disease (SD), assessed up to 12 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhongda Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: