Phase II Study Evaluating the Efficacy of Bevacizumab (Avastin@) in Hepatocellular Carcinoma Not Amenable to Curative Treatment
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- The main response parameter will be the disease control rate, defined by the objective response and stable disease rate (Response Evaluation Criteria in Solid Tumors [RECIST criteria]) after two consecutive tumor evaluations during treatment.
研究概览
简要总结
Primary liver cancer (hepatocellular carcinoma) is the fifth most common malignant disorder, with an increasing incidence in Europe and the USA as a result of the high prevalence of hepatitis C. Most patients are not suitable for potentially curative treatment. There is no standard palliative treatment for patients with advanced hepatocellular carcinoma (HCC), as no drug has been demonstrated to be efficient in this disease in terms of survival. The use of anti-vascular agents might be a promising approach in view of the highly vascular nature of this tumor. The aim of this phase II trial is to evaluate the potential benefit of bevacizumab in terms of disease control rate, progression-free and overall survival in adult patients with advanced primary liver cancer. Bevacizumab is an angiogenesis inhibitor already successfully used in patients with colorectal and renal cancers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically proven HCC or alpha-fetoprotein level > 400 ng/ml together with hypervascular tumor and cirrhosis documented by CT scan or MRI.
- •HCC not amenable to curative treatment (resection, transplantation, percutaneous ablation)
- •Presence of at least one dimensionally measurable target lesion with largest diameter >= 2 cm.
- •No previous chemoembolization, no previous radiotherapy
- •Cancer of the Liver Italian Program (CLIP) score < 4
- •World Health Organization (WHO) performance status of 2 or less
- •Life expectancy >= 3 months.
- •Age >= 18 years.
- •Adequate hematologic functions (neutrophil count, at least 1500 per cubic millimeter; platelet count, at least 75,000 per cubic millimetre; Hemoglobin, at least 8 g/dl)
- •Adequate liver function (bilirubin, not more than 2 times the upper limit of normal); Adequate renal function (serum creatinine, less than 150 micromol per liter)
- •Adequate coagulation function
- •Written informed consent
排除标准
- •Decompensated cirrhosis (Child-Pugh score > 7)
- •CLIP score > 4
- •Variceal bleeding during the previous 3 months
- •Thromboembolic event during the previous 6 months
- •Medical condition requiring full dose anticoagulation or anti-platelet drugs
- •Abnormal cardiac function with history of ischemic heart disease in the previous 6 months, uncontrolled hypertension, unstable angina, severe cardiac arrhythmia,
- •No brain metastasis, No bone metastasis only
- •Previous or current malignancies at other sites
- •No concomitant antitumor treatment including tamoxifen or somatostatin analogs
- •Unstable systemic diseases or active uncontrolled infections.
- •Patients (male and female) not using effective contraception if of reproductive potential.
结局指标
主要结局
The main response parameter will be the disease control rate, defined by the objective response and stable disease rate (Response Evaluation Criteria in Solid Tumors [RECIST criteria]) after two consecutive tumor evaluations during treatment.
次要结局
- Overall survival, progression-free survival, toxicity (National Cancer Institute-Common Toxicity Criteria Version 3 [NCI-CTC V3])
- Evaluation of vascular changes will be performed using Doppler ultrasound with injection of sonographic contrast agent