Statin for Preventing Hepatocellular Carcinoma Recurrence After Curative Treatment: a Double-blind Randomized Placebo-controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 240
- 试验地点
- 6
- 主要终点
- 3-year cumulative incidence of recurrent HCC between the intervention group and control counterpart
研究概览
简要总结
The purpose of this study is to evaluate whether statin could prevent recurrence of hepatocellular carcinoma after curative treatment
详细描述
This is a multi-center double-blind randomized placebo-controlled trial. A total of 240 patients with HCC at BCLC stage 0 or A will be enrolled from 8 hospitals in Taiwan. After complete ablation or hepatic resection of the tumor(s), participants are randomized 1:1 to receive either atorvastatin 10mg once daily (intervention group) or matched placebo (control group) for 3 years. During the 3-year period, patients are monitored for recurrence of HCC by dynamic computed tomography (or magnetic resonance image) every 4 months. They will be followed up until death, withdrawal from participation, study termination, or 3 years after the ablative treatment. The primary endpoint is to compare the 3-year cumulative incidence of recurrent HCC between the intervention group and control counterpart. Secondary endpoints are occurrence of clinical complications related to hepatic decompensation (including gastroesophageal variceal bleeding, spontaneous peritonitis, hepatic encephalopathy, hepatorenal syndrome, and hepatopulmonary syndrome), liver-related mortality, and all-cause mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with HCC BCLC stage 0 or A who received curative radiofrequency ablation or hepatic resection could be eligible.
- •Individuals who had single HCC (size > 5.0 cm) received hepatic resection would be eligible
- •Individuals with prior history of HCC who had ever received curative ablation or hepatic resection without any recurrence for more than 2 years could be eligible if they had a new episode of recurrent HCC which could meet either of the former two criteria.
- •After 12+/-1 weeks of curative treatment, eligible patients who have no evidence of local residual or recurrent tumors according to the dynamic CT or MRI could be enrolled
- •The diagnosis of fresh HCC should be compatible with either pathological report or meet the criteria of AASLD guidelines
排除标准
- •Undetermined nature of hepatic tumor
- •HCC with extrahepatic metastasis or major vascular invasion
- •With other malignant disease
- •Child Pugh score >7
- •Previous history of CAD event (angina, unstable angina, acute myocardial infarction) or ischemic stroke
- •Hyperlipidemia or other indication for statin (according to Taiwan NHI guideline)
- •Advanced CKD (eGFR<30) or ESRD
- •Severe comorbidity with life expectancy < 2 years
- •Allergy to statin
研究组 & 干预措施
Statin
Atorvastatin 10mg oral once daily
干预措施: Atorvastatin (Drug)
Placebo
Matched placebo (sugar pill) once daily
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
3-year cumulative incidence of recurrent HCC between the intervention group and control counterpart
时间窗: 3 years
Recurrence rate of HCC
次要结局
- occurrence of clinical complications related to hepatic decompensation(3 years)