NCT02008929已完成2 期
A Single Center, Open-label, Phase II Clinical Trial to Evaluate the Efficacy and Safety of MG4101(Ex Vivo Expanded Allogeneic NK Cell) in Hepatocellular Carcinoma After Curative Resection
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Disease free survival, DFS
研究概览
简要总结
To see the safety and efficacy of injecting MG4101 as a secondary treatment after curative liver resection on the patient with advanced HCC who has high risk of recurrence.
详细描述
To see the safety and efficacy of injecting MG4101(Ex vivo expanded allogeneic NK cell) as a secondary treatment after curative liver resection on the patient with advanced HCC who has high risk of recurrence.
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
- 20 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Under the age of 20 to 69 years of age
- •Child-pugh class A
- •After curative liver resection, diagnosed hepatocellular carcinoma
- •Modified UICC staging : stage 3
- •the women who is childbearing age, agree to maintain adequate contraception measure during clinical trial period.
- •Agreed to participate in this clinical trial, agree to the subject person or legal representative who agrees in writing
排除标准
- •Less than 20 years old, 70 years old or older
- •Metastasis of hepatocellular carcinoma with external parties surgery
- •who had Rupture of hepatocellular carcinoma (HCC)
- •Hepatocellular carcinoma treated with radiofrequency surgery therapeutics (Radiofrequency ablation, RFA), the carotid artery chemical embolization (Transarterial chemoembolization, TACE), underwent radiation therapy, such as topical therapeutics
- •suspected serious infection
- •Who have severe cardiovascular disease (coronary artery disease requiring treatment, heart failure, arrhythmias, myocardial infarction, etc.)
- •Pregnant, planning a pregnancy or breast-feeding women
- •Autoimmune Disease
- •Those who Latest within four weeks of administration of systemic steroids (However, inhalation, intranasal corticosteroids and topical administration of corticosteroids and short-time administration of a blood transfusion, if such reasons are excluded)
- •Latest within four weeks of taking immunosuppressive drugs such as Cyclosporine A
- •Within the last 5 years diagnosed with liver cancer and other malignancies
- •Investigator did not complete or the effectiveness or safety of pharmaceutical products of this clinical trial evaluation for any medical condition that can interfere with characters judged
结局指标
主要结局
Disease free survival, DFS
时间窗: Disease free survival for 1year
As of Date for allocation to survival and recurrence of the incident or death from any cause is defined as. 1 year disease-free survival was calculated using Kaplan-Meier estimation and 95% confidence interval and median survival (median survival time) are presented.
次要结局
- Changes in tumor markers(Changes in tumor markers. to be specific, alpha-fetoprotein(AFP), protein induced by vitamin K absence- II(PIVKA-II))
- Overall survival, OS(Overall survival, OS at the end point of clinical trial)
研究者
JAE WON JOH
Clinical Professor
Samsung Medical Center
研究点 (2)
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