NCT07075562

TACE Plus Bevacizumab for Hepatocellular Carcinoma With Portal Vein Invasion

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: The First Hospital of Hebei Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hepatocellular Carcinoma (HCC)

Interventions

Type	Name	Description
DRUG	Bevacizumab Arterial Perfusion plus TACE	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).
PROCEDURE	Conventional Therapy	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.

Timeline

• Start date: 2021-06-01
• Primary completion: 2024-03-31
• Completion: 2025-05-30
• First posted: 2025-07-20
• Last updated: 2025-07-20

Locations

1 site across 1 country: China