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NCT Number: NCT07075562

TACE Plus Bevacizumab for Hepatocellular Carcinoma With Portal Vein Invasion

This is a prospective, randomized study designed to compare the efficacy of transcatheter hepatic artery chemoembolization (TACE) combined with bevacizumab arterial perfusion versus conventional therapy in patients with hepatocellular carcinoma (HCC) invading the portal vein. The study aims to evaluate the effects on tumor load, angiogenesis, and survival outcomes.

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Key information

Conditions

Hepatocellular Carcinoma (HCC) Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050023, China

About this study

Hepatocellular carcinoma (HCC) with portal vein invasion has a poor prognosis and limited therapeutic options. Transcatheter hepatic artery chemoembolization (TACE) is a standard locoregional therapy, but its efficacy can be limited by hypoxia-induced angiogenesis. Bevacizumab, a VEGF inhibitor, can counteract this angiogenic rebound. This study was designed to investigate the potential synergistic effects of combining TACE with bevacizumab arterial perfusion. A total of 180 patients with portal vein-invasive HCC were prospectively recruited and randomized to either the combination therapy group or a conventional therapy control group. The primary objectives were to assess changes in tumor load (size and number), serum angiogenic factors (VEGF and PDGF), and tumor vascular density. Secondary objectives included evaluating safety and comparing progression-free and overall survival between the two groups to establish an evidence-based framework for this treatment strategy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged between 18 and 70 years.
  • Confirmed diagnosis of Hepatocellular Carcinoma (HCC) with radiological evidence of portal vein invasion.
  • Preserved liver function (Child-Pugh class A or B).
  • Absence of severe cardiac, renal, or other vital organ dysfunctions.
  • Complete clinical and follow-up data available.
  • Provided written informed consent.

Exclusion criteria

  • History of other malignancies within the past five years.
  • Prior or planned liver transplantation.
  • Severe comorbidities (e.g., decompensated cirrhosis, active bleeding, or cardiac disease).
  • Pregnant or lactating women.
  • Known hypersensitivity to bevacizumab or other components of the treatment.

Treatment and study plan

Bevacizumab Arterial Perfusion plus TACE

Drug

The intervention consists of a combination treatment. Patients undergo transcatheter hepatic artery chemoembolization (TACE), a procedure involving localized delivery of chemotherapy and embolization of the tumor-feeding arteries. This is combined with a targeted arterial perfusion of bevacizumab, a monoclonal antibody that inhibits vascular endothelial growth factor (VEGF).

Conventional Therapy

Procedure

Patients in the control group received conventional therapy, which typically consists of TACE alone for this patient population. This involves the selective catheterization of hepatic arteries supplying the tumor, followed by the infusion of chemotherapeutic agents and an embolic agent to induce tumor necrosis.

Primary outcomes

  1. Change in Tumor Load

    Time frame: Baseline (before treatment) and 3 months post-treatmen

    Measured by assessing the change in tumor diameter (in cm) and the total number of tumors from baseline. Measurements are performed using Magnetic Resonance Imaging (MRI).

  2. Change in Serum Angiogenic Factors

    Time frame: Baseline (before treatment) and at the 3-month post-treatment follow-up

    Measured by the change in serum levels of Vascular Endothelial Growth Factor (VEGF) and Platelet-Derived Growth Factor (PDGF) in pg/mL, as quantified by Enzyme-Linked Immunosorbent Assay (ELISA).

  3. Change in Tumor Vascular Density

    Time frame: Baseline (before treatment) and 3 months post-treatment

    Measured as the change in the density of blood vessels (vessels/cm²) in the tumor area, evaluated by Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI).

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: From date of randomization until death, with a median follow-up of 24 months (range 12-36 months)

    Time from randomization to death from any cause. Reported as median survival in months.

  2. Progression-Free Survival (PFS)

    Time frame: From date of randomization until disease progression or death, assessed at 6-month intervals up to 36 months

    Time from randomization to disease progression or death from any cause, whichever occurs first. Reported as median survival in months.

  3. Incidence of Adverse Events

    Time frame: From the start of the first intervention until the 3-month post-treatment follow-up visit

    Number and percentage of participants experiencing treatment-related adverse events, graded according to CTCAE v5.0.

Sponsors and collaborators

Lead sponsor

The First Hospital of Hebei Medical University

Other

Registry information

Official study title

Effects of Transcatheter Hepatic Arterial Chemoembolization (TACE) and Bevacizumab Arterial Perfusion on Tumor Load and Angiogenesis in Patients With Hepatocellular Carcinoma Invading Portal Vein

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Jul 20, 2025
Registry last updated
Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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