Effects of Transcatheter Hepatic Arterial Chemoembolization (TACE) and Bevacizumab Arterial Perfusion on Tumor Load and Angiogenesis in Patients With Hepatocellular Carcinoma Invading Portal Vein
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Change in Tumor Load
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Experimental: Observation Group (TACE + Bevacizumab)
Patients randomized to this arm received transcatheter hepatic artery chemoembolization (TACE) combined with arterial infusion of bevacizumab.
干预措施: Bevacizumab Arterial Perfusion plus TACE (Drug)
Active Comparator: Control Group (Conventional Therapy)
Patients randomized to this arm received conventional therapy for HCC with portal vein invasion, serving as the active control.
干预措施: Conventional Therapy (Procedure)
结局指标
主要结局
Change in Tumor Load
时间窗: 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
时间窗: 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
时间窗: 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).
次要结局
- 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)
研究者
Bingzheng Yan
Principal investigator
The First Hospital of Hebei Medical University