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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
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).
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.
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
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).
Time frame: 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).
Time frame: 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).
Time frame: Baseline (before treatment) and 3 months post-treatment
Overall Survival (OS)
Time from randomization to death from any cause. Reported as median survival in months.
Time frame: From date of randomization until death, with a median follow-up of 24 months (range 12-36 months)
Progression-Free Survival (PFS)
Time from randomization to disease progression or death from any cause, whichever occurs first. Reported as median survival in months.
Time frame: From date of randomization until disease progression or death, assessed at 6-month intervals up to 36 months
Incidence of Adverse Events
Number and percentage of participants experiencing treatment-related adverse events, graded according to CTCAE v5.0.
Time frame: From the start of the first intervention until the 3-month post-treatment follow-up visit
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