Hepatocellular Carcinoma (HCC)
Conditions
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.
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.
Interventions
DRUGBevacizumab 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).
PROCEDUREConventional 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.
Sponsors
The First Hospital of Hebei Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Tumor Load | 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). |
| Change in Serum Angiogenic Factors | 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). |
| Change in Tumor Vascular Density | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | 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. |
| Progression-Free Survival (PFS) | 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. |
| Incidence of Adverse Events | 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. |
Countries
China
Outcome results
None listed