NCT04172779尚未招募2 期
Phase II Clinical Trial of Low-dose Erlotinib for Hepatocellular Carcinoma Chemoprevention
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Modulation of serum protein signature associated with hepatocellular carcinoma (HCC) risk
研究概览
简要总结
This phase II randomized placebo-controlled trial studies low-dose erlotinib treatment to assess its efficacy and safety to prevent development of hepatocellular carcinoma in patients with advanced liver fibrosis or cirrhosis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Adults (≥ 18 years-old)
- •Clinically and/or histologically diagnosed advanced liver fibrosis or cirrhosis
- •No active hepatic decompensation
- •No prior history of HCC
- •FIB-4 index > 3.25
- •PLSec score ≥ 3
- •Adequate hematologic, hepatic, and renal function, Karnofsky performance status score ≥70
- •Both sexes and all racial/ethnic groups will be considered
排除标准
- •Prior treatment with epidermal growth factor receptor (EGFR) inhibitors
- •Uncontrolled intercurrent, use of CYP3A4 modulators
- •Erlotinib treatment <4 weeks or <80% of planned regimen at the end of week 4
- •HCC development during the study
研究组 & 干预措施
Erlotinib treatment
Experimental
干预措施: erlotinib hydrochloride (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Modulation of serum protein signature associated with hepatocellular carcinoma (HCC) risk
时间窗: Baseline, 24 weeks
The relationship between the treatment and modulation of a serum protein signature associated with HCC risk (PLSec) will be assessed. PLSec-based HCC risk level (i.e., PLSec score) will be compared between baseline and at the end of treatment, and magnitude of the modulation will be measured as delta-PLSec and compared between the treatment groups by t-test and Wilcoxon rank-sum test.
次要结局
- Overall adverse event profile for erlotinib hydrochloride(Baseline, 24 weeks)
- Change in quality of life (QOL)(Baseline, 24 weeks)
研究者
Yujin Hoshida, MD, PhD
Professor
University of Texas Southwestern Medical Center
研究点 (2)
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