Increased Dose, Repeated Injection Clinical to Evaluate the Efficacy and Safety of 'Immuncell-LC' in Patients Undergoing Liver Transplantation With Hepatocellular Carcinoma Exceeding the Milan Criteria
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- maximum tolerated dose (MTD) or maximum feasible dose (MFD)
研究概览
简要总结
The purpose of this study is to investigate and validate the maximum tolerated dose (MTD) or maximum available dose (MFD), safety and efficacy on patients with hepatocellular carcinoma beyond Milan criteria who undergo liver transplantation.
详细描述
ILC-IIT-07 is open-label, phase 1/2 clinical trial to confirm safety on patients with hepatocellular carcinoma beyond Milan criteria who undergo liver transplantation. For primary outcome, maximum feasible dose (MFD) or maximum tolerated dose (MTD) will be evaluated.
For secondary outcome, Time to Recurrence(TTR), Recurrence-Free Survival(RFS), Overall Survival(OS) will be evaluated.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are more than 20 and less than 80 years old.
- •Patients whose expected life expectancy is at least 16 weeks (4 months).
- •Patients who receive liver transplants exceeding the Milan Criteria.
- •ECOG Performance Status (ECOG-PS) score is 0-
- •Patients who satisfy the following conditions of the blood test and kidney, liver function test.
- •Absolute neutrophil count > 500x10^6L Hemoglobin ≥ 7.5 g/dL Platelet count > 20,000/㎣ Total bilirubin < 15mg/㎗
- •Patients who have agreed to participate in the study voluntarily by signing on informed consent form.
排除标准
- •Patients who have received in vitro radiation therapy, systemic chemotherapy within 4 weeks based on sign date of Informed consent form.
- •Patients who undergo ABO incompatible Liver Transplantation.
- •Patients who had previously administered cell therapy.
- •Patients who are confirmed with Acquired Immune Deficiency Syndrome (AIDS).
- •Patients who are currently receiving dialysis.
- •Patients who participated in another clinical trial and received treatment in 4 weeks or have a plan for administration of another clinical trial treatment since Informed consent form sign date.
- •Patients who have uncontrollable or serious disease.
- •Patients who are unable to use appropriate methods of contraception during the study period.
- •Patient whose tumor has not been removed or liver metastasis is confirmed.
结局指标
主要结局
maximum tolerated dose (MTD) or maximum feasible dose (MFD)
时间窗: Every visit from the baseline until 44 weeks, and then every 3 months until the data cut-off date or 12 months from baseline of last subject
The observation of maximum tolerated dose (MTD) or maximum feasible dose (MFD) evaluation(1X10\^7cell, 5X10\^7cell, 10X10\^7cells) of immuncell-LC on hepatocellular carcinoma patients who undergo liver transplantation
次要结局
- Recurrence-Free Survival(Every visit from the baseline until 44 weeks, and then every 3 months until the data cut-off date or 12 months from baseline of last subject)
- Overall Survival(Every visit from the baseline until 44 weeks, and then every 3 months until the data cut-off date or 12 months from baseline of last subject)
- Time to Recurrence(Every visit from the baseline until 44 weeks, and then every 3 months until the data cut-off date or 12 months from baseline of last subject)