Autologous natural killer cells and hepatic arterial infusion chemotherapy in hepatocellular carcinoma

Not Applicable

Recruiting

Conditions: Neoplasms

Registration Number: KCT0003973

Lead Sponsor: Chonnam National University Hospital Hwasun Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 12

Inclusion Criteria

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

Exclusion Criteria

- 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

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
• Primary outcome measure : Safety (time frame : 2 month)

Secondary Outcome Measures

Name	Time	Method
Immunological feasibility, 1) NK cell analysis (CD3/CD56+), 2) T cell analysis(CD4, CD8), 3) Serum cytokine analysis,;1) Response analysis by mRECIST, 2) Quality of life by physical wellbeing, social/family wellbeing, emotional wellbeing, functional wellbeing, additional concerns