TACE Plus Bevacizumab for Hepatocellular Carcinoma With Portal Vein Invasion

Hebei Medical University

Status: Completed

Conditions: Hepatocellular Carcinoma (HCC)

Treatments: Drug: Bevacizumab Arterial Perfusion plus TACE; Procedure: Conventional Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07075562

20220685

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 180 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Experimental: Observation Group (TACE + Bevacizumab)

Experimental group

Description:

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

Treatment:

Drug: Bevacizumab Arterial Perfusion plus TACE

Active Comparator: Control Group (Conventional Therapy)

Active Comparator group

Description:

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

Treatment:

Procedure: Conventional Therapy