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

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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0003973

Enrollment

Registered

2019-05-22

Start date

2016-05-02

Completion date

Unknown

Last updated

2019-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug, Biological/Vaccine, Non-Stem Cell : · Procedure : HAIC using 5-FU plus Cisplatin Hepatic arterial infusion chemotherapy using 5-FU plus Cisplatin · Drug : 5-FU 5-FU, 750 mg/m2, intraarterial

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Secondary

Measure	Time frame
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	—

Primary

Measure	Time frame
• Primary outcome measure : Safety (time frame : 2 month)	—

Countries

Korea, Republic of

Contacts

Public ContactYangseok Koh

Chonnam National University Hospital Hwasun Hospital

yskoh3324@gmail.com+82-61-379-7650

Outcome results