Statin Combination Therapy in Patients Receiving Sorafenib for Advanced Hepatocellular Carcinoma: A Randomized Controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
Target therapy with sorafenib is the standard of treatment for advanced Hepatocellular carcinoma (HCC), but the patient survival time is still unsatisfactory. The aims of this study are to prove statins improve the tumor responses and overall survival for patients who receive sorafenib therapy for advanced HCC by a prospective randomized controlled study.
详细描述
Background:
Hepatocellular carcinoma (HCC) is the second leading cause of cancer death worldwide, including the condition in Taiwan, and the management of HCC is an important challenge in public health. Target therapy with sorafenib is the standard of treatment for advanced HCC (vascular invasion or extrahepatic metastasis), but the patient survival time is still unsatisfactory. In recent years, growing evidences, including mechanism analysis, have suggested the anitneoplastic effects of statin, and a recent pooled analysis found that statin use may be associated with improved survival in patients with metastatic rencal cell carcinoma. However, a prospective clinical trial of statin sorafenib combination therapy in the treatment of advanced HCC is lacking.
Aims:
- To prove statins improve the overall survival for patients who receive sorafenib therapy for advanced HCC by a prospective randomized controlled study.
- To prove statin can improve tumor responses and the progression free survival for patients who receive sorafenib therapy for advanced HCC by a prospective randomized controlled study.
Methods:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients more than 40 years old
- •HCCs diagnosed by AASLD image criteria or pathology
- •HCCs in BCLC advanced stage, with portal vein thrombosis (VP3 or VP4) or extrahepatic metastasis
- •Not suitable or failed to locoreginal treatments for HCC
- •Child-Pugh score = or < 6
- •ECOG performance status (PST) 0-2
- •Serum bilirubin < 2 mg/dL and prothrombin time (PT) prolongation < 3 seconds
- •Will receive sorafenib therapy
- •Life expectancy > 3 months
- •Will follow the pregnancy prevention protocol
排除标准
- •HCC is considered for curative therapy
- •HCC with brain metastasis
- •History of systemic therapy for HCC
- •Indications for statin use, such as hyperlipidemia in cardiovascular diseases
- •Any local treatment for HCC within 4 weeks
- •Any active gastrointestinal bleeding within 4 weeks
- •Liver transplant history or concomitant immunosuppressive therapy
- •Concurrent any other malignancy
- •Allergy to sorafenib or statins
- •Pregnancy or lactation
- •Serum AST or ALT > 5x upper limit of normal
- •Known HIV infection
- •eGFR < 30 ml/min
- •Abnormal medical conditions that are unsuitable for study, such as uncontrolled hypertension, coronary arterial disease, or arrhythmia
研究组 & 干预措施
Statin treated group
干预措施: Atorvastatin 10mg (Drug)
Control group
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Overall survival
时间窗: Three year
次要结局
- Best tumor response(Three year)
- Progression free survival(Three year)
研究者
Teng-Yu Lee
MD, PhD
Taichung Veterans General Hospital