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

NCT ID: NCT02487017

Last Updated: 2016-05-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2018-12-31

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.

Conditions

Hepatocellular Carcinoma; Neoplasms; Digestive System Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Transcatheter Arterial Chemoembolization

Transcatheter Arterial Chemoembolization treatment according to NCCN guidelines，patients will receive 5-FU Hepatic arterial infusion,3 cycles at least.

Group Type: SHAM_COMPARATOR

Transcatheter Arterial Chemoembolization (TACE)

Intervention Type: PROCEDURE

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

After accepting concurrent TACE according to NCCN guidelines,patients will receive 3 cycles of DC-CIK treatment at least.

Group Type: EXPERIMENTAL

DC-CIK

Intervention Type: BIOLOGICAL

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

Interventions

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

Intervention Type: PROCEDURE

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yantai City Hospital for Infectious Diseases

UNKNOWN

Sponsor Role: collaborator

Shenzhen Hornetcorn Bio-technology Company, LTD

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiangzhong Liu, Professor

Role: PRINCIPAL_INVESTIGATOR

Yantai City Hospital for Infectious Diseases Immunotherapy center

Locations

Yantai City Hospital for Infectious Diseases

Yantai, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiangzhong Liu, Professor

Role: CONTACT

xiangzhong8686@sina.com

0535-6606236

Facility Contacts

Xiangzhong Liu, Professor

Role: primary

0535-6606193

Other Identifiers

HYK-Hepatocellular Carcinoma

Identifier Type: -

Identifier Source: org_study_id