Hepatocellular Carcinoma, Neoplasms, Digestive System Neoplasms
Conditions
Brief summary
Evaluation of DC-CIK cells combined TACE treatment for HCC
Detailed description
60 patients with Hepatocellular Carcinoma, who had received Transcatheter Arterial Chemoembolization (TACE) , will be randomly divided into group A (receive DC-CIK+ TACE treatment) or group B (just receive TACE), and the randomize ratio will be 1:1.
Interventions
BIOLOGICALDC-CIK
Transcatheter Arterial Chemoembolization (TACE): 5-FU 400mg/m2 Hepatic arterial infusion ,lipiodol amount is usually 20 ml, the perfusion time should not be less than 20 min DC-CIK: 8×10\^9 DC-CIK cells for each infusion, IV (in the vein) for each infusion at least 3 cycles, each cycle received four infusions on day 14, 16, 30 and 32
Transcatheter Arterial Chemoembolization (TACE): 5-FU 400mg/m2 Hepatic arterial infusion ,lipiodol amount is usually 20 ml,the perfusion time should not be less than 20 min
Sponsors
Yantai City Hospital for Infectious Diseases
Shenzhen Hornetcorn Bio-technology Company, LTD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 18-80 years old; * Histologically confirmed with Hepatocellular Carcinoma at stage I-II; * Patients who can accept Transcatheter Arterial Chemoembolization ; * Patients who have a life expectancy of at least 3 months; * Patients who have a Child-Pugh:A/B; .Eastern Cooperative Oncology Group (ECOG) performance status was 0-2.
Exclusion criteria
* White blood cell \<3 x 10\^9/L,Platelet count \<75 x 10\^9/L;BUN and Cr more than normal limits on 3.0 times ; * Known or suspected allergy to the investigational agent or any agent given in association with this trial; * Pregnant or lactating patients; * Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection; * Patients who are suffering from serious autoimmune disease; * Patients who had used long time or are using immunosuppressant; * Patients who had active infection; * Prior use of any anti-cancer treatment in 30 days; * Now or recently will join another experimental clinical study ; * History of organ allograft; * Other situations that the researchers considered unsuitable for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Progress-free survival | 3 years |
| Quality of life (QOL) | 3 years |
| Phenotypic analysis of T cells | 1 years |
Countries
China
Contacts
Primary ContactXiangzhong Liu, Professor
Outcome results
None listed