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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02487017
Other study ID # HYK-Hepatocellular Carcinoma
Secondary ID
Status Recruiting
Phase Phase 2
First received June 29, 2015
Last updated May 23, 2016
Start date May 2015
Est. completion date December 2018

Study information

Verified date December 2015
Source Shenzhen Hornetcorn Bio-technology Company, LTD
Contact Xiangzhong Liu, Professor
Phone 0535-6606236
Email xiangzhong8686@sina.com
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Evaluation of DC-CIK cells combined TACE treatment for HCC


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
Transcatheter Arterial Chemoembolization (TACE)
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
Biological:
DC-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

Locations

Country Name City State
China Yantai City Hospital for Infectious Diseases Yantai Shandong

Sponsors (2)

Lead Sponsor Collaborator
Shenzhen Hornetcorn Bio-technology Company, LTD Yantai City Hospital for Infectious Diseases

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival 3 years No
Secondary Progress-free survival 3 years No
Secondary Quality of life (QOL) 3 years No
Secondary Phenotypic analysis of T cells 1 years No
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