Back to resultsCIK Treatment for HCC Patient Underwent Radical Resection
Primary Purpose
Carcinoma, Hepatocellular
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Cytokine-Induced Killer Cells
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Hepatocellular
Eligibility Criteria
Inclusion Criteria:
- Male or female patients over 18 years of age.
- Without any prior anti-cancer therapy.
- Patients who have a life expectancy of at least 12 weeks.
- Patients already had radical resection of HCC.
Definition of radical resection in this study:
- All tumors were moved out, with a clean resection margin.
- Number of tumors less than 3.
- Without tumor invasion of the main trunk and first branch of the portal vein, or hepatic duct, or hepatic vein.
- No hepatic hilum lymphnode metastasis.
- No distance metastasis.
- Hepatocellular carcinoma with histological diagnose.
- No major post-operative complication.
- Patients who have an performance status of 0, or 1.
- Cirrhotic status of Child-Pugh class A only.
- The following laboratory parameters:
- Patients who give written informed consent.
Exclusion Criteria:
- Previous or concurrent cancer that is distinct in primary site or histology from HCC.
- History of cardiac disease.
- Active clinically serious infections ( over grade 2 National Cancer Institute-Common Terminology Criteria for Adverse Events version 3.0)
- Known history of human immunodeficiency virus (HIV) infection
- Known Central Nervous System tumors including metastatic brain disease.
- Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
- History of organ allograft.
- Known or suspected allergy to the investigational agent or any agent given in association with this trial.
- Pregnant or breast-feeding patients.
- Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study.
- Excluded therapies and medications, previous and concomitant:
Prior use of any anti-cancer treatment for HCC, eg. chemotherapy, radiotherapy. Antiviral treatment is allowed.
Sites / Locations
- Immunotherapy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
A, CIK
B, CONTROL
Arm Description
Biological/Vaccine: Cytokine-Induced Killer Cells
Regular follow up with no intervention
Outcomes
Primary Outcome Measures
Time to recurrence
To evaluate efficacy of CIK treatment as an adjuvant therapy in patients with hepatocellular carcinoma (HCC) who underwent radical resection.
Secondary Outcome Measures
Disease Free Survival
Disease Free Survival
Full Information
NCT ID
NCT01749865
First Posted
December 12, 2012
Last Updated
April 13, 2016
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT01749865
Brief Title
CIK Treatment for HCC Patient Underwent Radical Resection
Official Title
A Randomized Controlled Study of Cytokine-induced Killer Cell (CIK) Treatment in Patients With Hepatocellular Carcinoma Who Underwent Radical Resection
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a randomized controlled study. About 200 patients with hepatocellular carcinoma who underwent radical resection will be included. The patients will be randomized to group A (receive CIK treatment) or group B (just regularly follow up) without any anti-cancer treatment after resection of HCC, 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
Carcinoma, Hepatocellular
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A, CIK
Arm Type
Experimental
Arm Description
Biological/Vaccine: Cytokine-Induced Killer Cells
Arm Title
B, CONTROL
Arm Type
No Intervention
Arm Description
Regular follow up with no intervention
Intervention Type
Biological
Intervention Name(s)
Cytokine-Induced Killer Cells
Other Intervention Name(s)
CIK
Intervention Description
Cytokine-Induced Killer Cells treatment for 4 cycles
Primary Outcome Measure Information:
Title
Time to recurrence
Description
To evaluate efficacy of CIK treatment as an adjuvant therapy in patients with hepatocellular carcinoma (HCC) who underwent radical resection.
Time Frame
5-year
Secondary Outcome Measure Information:
Title
Disease Free Survival
Description
Disease Free Survival
Time Frame
5 year
Other Pre-specified Outcome Measures:
Title
Adverse Events
Description
To evaluate safety of CIK treatment as an adjuvant therapy in patients with hepatocellular carcinoma (HCC) who underwent radical resection.
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patients over 18 years of age.
Without any prior anti-cancer therapy.
Patients who have a life expectancy of at least 12 weeks.
Patients already had radical resection of HCC.
Definition of radical resection in this study:
All tumors were moved out, with a clean resection margin.
Number of tumors less than 3.
Without tumor invasion of the main trunk and first branch of the portal vein, or hepatic duct, or hepatic vein.
No hepatic hilum lymphnode metastasis.
No distance metastasis.
Hepatocellular carcinoma with histological diagnose.
No major post-operative complication.
Patients who have an performance status of 0, or 1.
Cirrhotic status of Child-Pugh class A only.
The following laboratory parameters:
Patients who give written informed consent.
Exclusion Criteria:
Previous or concurrent cancer that is distinct in primary site or histology from HCC.
History of cardiac disease.
Active clinically serious infections ( over grade 2 National Cancer Institute-Common Terminology Criteria for Adverse Events version 3.0)
Known history of human immunodeficiency virus (HIV) infection
Known Central Nervous System tumors including metastatic brain disease.
Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
History of organ allograft.
Known or suspected allergy to the investigational agent or any agent given in association with this trial.
Pregnant or breast-feeding patients.
Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study.
Excluded therapies and medications, previous and concomitant:
Prior use of any anti-cancer treatment for HCC, eg. chemotherapy, radiotherapy. Antiviral treatment is allowed.
Facility Information:
Facility Name
Immunotherapy
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
12. IPD Sharing Statement
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CIK Treatment for HCC Patient Underwent Radical Resection
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