A phase 1 study using autologous natural killer cells in patients with hepatic arterial infusion chemotherapy - hepatocellular carcinoma

Chonnam National University Hospital Hwasun Hospital0 个研究点目标入组 12 人开始时间: 待定最近更新: 2019年6月17日

适应症

试验速览

暂无简介。

•Age range: 18 years ~ 80 years
•Child-Pugh class A (Point 5~6) or B (Point 7)
•Patients with advanced hepatocellular carcinoma who have shown response after 2 cycles of Hepatic arterial infusion of chemotherapy with 5-fluorouracil plus Cisplatin
•Indication of hepatic arterial infusion of chemotherapy
•- patients who cannot be treated with surgery, Transcathether chemoembolization
•- patients who have have multiple intrahepatic metastasis or main vessels invasion
•The following laboratory parameters;
•? Absolute neutrophil count (ANC) = 1,500 /uL, Platelet count = 75,000 /uL, Hemoglobin = 9 g/dL, Sesrum AST and ALT = 5 x ULN, Serum creatinine = 1.5 x ULN, INR <1.7 ?? PT < 4 seconds, Serum albumin > 3.5 g/dL, Total bilirubin < 2 mg/dL
•ECOG performance status of 0 or 1
•Ability to understand the protocol and to agree to and sign a written informed consent document

•- patients with extrahepatic tumors
•- Patients who participated as subjects in other interventional clinical studies within 4 weeks
•- Child-Pugh class B (point 8 and 9) or C
•- Patients who have sensitivity to 5-fluorouracil and Cisplain
•- patients who have history of liver transplantation

发起方

Chonnam National University Hospital Hwasun Hospital