An Open-Label Pilot Study to Evaluate Efficacy and Safety of Bevacizumab Via Transarterial Chemoembolization (TACE) in Patients With Liver Metastases
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Objective response rate
研究概览
简要总结
Trans arterial chemoembolization (TACE) has emerged as a treatment option for chemotherapy-refractory diseases in Liver metastases. By delivering chemotherapy agents directly to the tumor site, TACE can maximize local drug concentrations and reduce systemic adverse reactions. Bevacizumab is a monoclonal antibody that functions as an angiogenesis inhibitor. It works by slowing the growth of new blood vessels by inhibiting vascular endothelial growth factor A (VEGF-A). The application of Bevacizumab during TACE has not been reported. In this study, we will evaluate the the overall survival (OS)、efficacy, and safety of the application of Bevacizumab during TACE in patients with Liver Metastases by designing an open, single-arm phase II clinical study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmation of metastatic liver cancer via histological examination or a characteristic imaging profile on dynamic computed tomography (CT) scan or magnetic resonance imaging (MRI) without indications for surgical resection
- •Eastern cooperative oncology group performance status (ECOGPS) of 0 or 1
- •Liver function categorized as Child-Pugh class A or B
- •Stable non-hepatic metastases, such as skeletal, pulmonary, or lymph node metastases
- •Hepatic tumor burden below 70%
- •Expected survival duration exceeding six months
- •Laboratory findings meeting specific criteria, including platelet count >50×109 /L, hemoglobin >8.0 g/dL, ANC count ≥1.5 × 109/L, bilirubin <51 mmol/L, alanine and aspartate aminotransferase <3 times the upper limit of the normal range, and serum creatinine <1.5 times the upper limit of the normal range.
排除标准
- •Active infection
- •Presence of severe comorbidities, such as hepatic encephalopathy, refractory ascites, and esophageal variceal bleeding
- •Prior liver resection
- •Previous TACE therapy received at other healthcare facilities
- •Poor performance status (ECOGPS > 1)
研究组 & 干预措施
Bevacizumab Transarterial Chemoembolization
The procedure commences with local disinfection and anesthesia, followed by a percutaneous right femoral artery puncture, performed using a modified Seldinger technique. A 5-F Simmons Ⅰ catheter was introduced through a vascular sheath and positioned in the common hepatic artery with the guidance of digital subtraction angiography to identify the tumor-supplying vessels. A 2.8-F microcatheter catheter was advanced into the vessel supplying the hepatic tumor. In cases of bilobar disease, the initial treatment focus was on the lobe with the greatest tumor burden, with the contralateral lobe addressed in a subsequent TACE session scheduled 4-6 weeks apart. In the standard TACE protocol ( hepaspheres are loaded with Irinotecan at 50 mg for colon metastases and Idarubicin at 10 mg for breast metastases), Bevacizumab 50 mg-loaded hepaspheres was added. The procedure was monitored under fluoroscopy until arterial flow stasis was achieved.
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Objective response rate
时间窗: 6 months
The percentage of patients who achieved a complete or partial response at some point in their life
Overall Survival Rate
时间窗: 6 months
Percentage of patients who survived 6 months after inclusion
次要结局
- Adverse event(6 months)
研究者
Shahram Akhlaghpoor
Associate Professor of Vascular and Interventional Radiology
Pardis Noor Medical Imaging and Cancer Center