Safety Study of Nature Killer Cells From Sibship to Treat the Recurrence of Hepatocellular Carcinoma After Liver Transplantation
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- GVHD
研究概览
简要总结
The purpose of this study is to explore the safety of NK cells from Sibship in patients with recurrent hepatocellular carcinoma after liver transplantation.
详细描述
Hepatocellular carcinoma (HCC) is one of the indications for the liver transplantation. With the advancement of liver transplantation associated science and technology, the recurrence of tumor posttransplantation has become the principal contradiction to worsen the prognosis and therefore the prevention of recurrence of HCC is the key to improve the efficacy of liver transplantation. Adoptive cellular immunotherapy has been applied in various malignant tumors including HCC and has obtained significant effects. But for patients with liver transplant in immunosuppressed states, to successfully apply the immune cells to prevent and treat HCC relapse after liver transplantation must balance immunosuppression and anti-tumor immunity. It is necessary to consider the safety of adoptive cellular immunotherapy,and it is also necessary to consider the effectiveness of treatment that the immune cells in the immunosuppression state can exert anti-tumor effects. Natural killer cells (NK cells) have MHC-unrestricted killing effect on malignant tumor cells and are not major mediating cells for GVHD, and might be an optimum choice to meet the above requirements.
Patients with confirmed recurrence of hepatocellular carcinoma after liver transplantation at the Third Affiliated Hospital of Sun Yat-sen University were enrolled.Participants in the study will be assigned to one of three treatment arms:
Arm A: Participants will received conventional treatment and low dose of NK cells treatment for 4 times. Arm B: Participants will received conventional treatment and normal dose of NK cells treatment for 4 times. Arm C: Participants will received conventional treatment and normal dose of NK cells treatment for 8 times. The cultured NK cells from the peripheral blood of the same blood type were taken and infused at intervals of two weeks. Periodic liver function recheck and imaging examination were conducted for 6 months after the last NK cells infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Proved hepatocellular carcinoma histologically after liver transplantation.
- •Confirmed recurrence of hepatocellular carcinoma by CT/MRI.
- •The same blood type relatives with blood transmitted diseases negative.
- •Written informed consent.
排除标准
- •Autoimmune diseases require long-term of glucocorticoid.
- •Other candidates who are judged to be not applicable to this study by investigators.
- •Poor compliance.
研究组 & 干预措施
Arm A
Received conventional treatment and NK cells once per two-week for the first two-month, at a dose of 5×10E9 NK cells.
干预措施: Low Dose NK cells ×4 times (Biological)
Arm B
Received conventional treatment and NK cells once per two-week for the first two-month, at a dose of 1×10E10 NK cells.
干预措施: Normal Dose NK cells ×4 times (Biological)
Arm C
Received conventional treatment and NK cells once per two-week for the first four-month, at a dose of 1×10E10 NK cells.
干预措施: Normal Dose NK cells ×8 times (Biological)
结局指标
主要结局
GVHD
时间窗: 6 months
Rash, fever, diarrhea, jaundice etc. leukocyte, platelet, red blood cells reduce, abnormal liver function.Pathological biopsy if necessary.
次要结局
- Acute rejection(6 months)
研究者
Wang Guoying
Department of liver transplantation
Third Affiliated Hospital, Sun Yat-Sen University