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

Primary Purpose

Hepatocellular Carcinoma, Neoplasms, Digestive System Neoplasms

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Transcatheter Arterial Chemoembolization (TACE)
DC-CIK
Sponsored by
Shenzhen Hornetcorn Bio-technology Company, LTD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yantai City Hospital for Infectious DiseasesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Transcatheter Arterial Chemoembolization

DC-CIK

Arm Description

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

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

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Progress-free survival
Quality of life (QOL)
Phenotypic analysis of T cells

Full Information

First Posted
June 29, 2015
Last Updated
May 23, 2016
Sponsor
Shenzhen Hornetcorn Bio-technology Company, LTD
Collaborators
Yantai City Hospital for Infectious Diseases
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1. Study Identification

Unique Protocol Identification Number
NCT02487017
Brief Title
DC-CIK Combined With TACE in the Treatment of Hepatocellular Carcinoma
Official Title
Phase 2 Study of DC-CIK Cells Combined With TACE in the Treatment of Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen Hornetcorn Bio-technology Company, LTD
Collaborators
Yantai City Hospital for Infectious Diseases

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Neoplasms, Digestive System Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transcatheter Arterial Chemoembolization
Arm Type
Sham Comparator
Arm Description
Transcatheter Arterial Chemoembolization treatment according to NCCN guidelines，patients will receive 5-FU Hepatic arterial infusion,3 cycles at least.
Arm Title
DC-CIK
Arm Type
Experimental
Arm Description
After accepting concurrent TACE according to NCCN guidelines,patients will receive 3 cycles of DC-CIK treatment at least.
Intervention Type
Procedure
Intervention Name(s)
Transcatheter Arterial Chemoembolization (TACE)
Intervention Description
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
Biological
Intervention Name(s)
DC-CIK
Intervention Description
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
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Progress-free survival
Time Frame
3 years
Title
Quality of life (QOL)
Time Frame
3 years
Title
Phenotypic analysis of T cells
Time Frame
1 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiangzhong Liu, Professor
Phone
0535-6606236
Email
xiangzhong8686@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiangzhong Liu, Professor
Organizational Affiliation
Yantai City Hospital for Infectious Diseases Immunotherapy center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yantai City Hospital for Infectious Diseases
City
Yantai
State/Province
Shandong
ZIP/Postal Code
264000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangzhong Liu, Professor
Phone
0535-6606193

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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