TACE Plus Bevacizumab for Hepatocellular Carcinoma With Portal Vein Invasion

NCT07075562 | Completed

• 1 other identifier: 20220685
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Carcinoma (HCC)

Outcome Measures

Primary Outcomes (3)

• Change in Tumor Load

  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).

  Baseline (before treatment) and 3 months post-treatmen

• Change in Serum Angiogenic Factors

  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).

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

• Change in Tumor Vascular Density

  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).

  Baseline (before treatment) and 3 months post-treatment

Secondary Outcomes (3)

• Overall Survival (OS)

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

• Progression-Free Survival (PFS)

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

• Incidence of Adverse Events

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

Study Arms (2)

Experimental: Observation Group (TACE + Bevacizumab)

EXPERIMENTAL

Patients randomized to this arm received transcatheter hepatic artery chemoembolization (TACE) combined with arterial infusion of bevacizumab.

Drug: Bevacizumab Arterial Perfusion plus TACE

Active Comparator: Control Group (Conventional Therapy)

ACTIVE COMPARATOR

Patients randomized to this arm received conventional therapy for HCC with portal vein invasion, serving as the active control.

Procedure: Conventional Therapy

Interventions

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).

Experimental: Observation Group (TACE + Bevacizumab)

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.

Active Comparator: Control Group (Conventional Therapy)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Hospital of Hebei Medical University: lead

Study Sites (1)

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050023, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 20, 2025
• Study Start: June 1, 2021
• Primary Completion: March 31, 2024
• Study Completion: May 30, 2025
• Last Updated: July 20, 2025

Record last verified: 2025-07

Locations

CN (1)