DC-CIK Combined With TACE in the Treatment of Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

Phase 2 Study of DC-CIK Cells Combined With TACE in the Treatment of Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02487017
• Other study ID #: HYK-Hepatocellular Carcinoma
• 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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Hepatocellular Carcinoma
• Neoplasms

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