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Study of Cytokine-induced Killer Cell (CIK) Treatment in Patients After Resection of Liver Cancer (HCC-CIK)

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
cytokine-induced killer cell (CIK) treatment
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring hepatocellular carcinoma, recurrent, cytokine-induced killer cell

Eligibility Criteria

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

Inclusion Criteria

  • Male or female patients > 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 <= 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 ECOG PS of 0, or 1.
  • Cirrhotic status of Child-Pugh class A only.

  • The following laboratory parameters:

    • Platelet count >= 70 x 109/L
    • Hemoglobin >= 8.5 g/dL
    • Albumin >= 3.5 g/dL
    • Total bilirubin <= 25umol/L
    • Alanine transaminase (ALT) and AST <= 2.5 x upper limit of normal
    • Serum creatinine <= 1.5 x the upper limit of normal
    • Prothrombin time (PT) <= 3 seconds above control.
    • 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 (> grade 2 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] 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

  • Sun Yat-sen University Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

B (control group)

A (CIK group)

Arm Description

regular treatment and follow up

cytokine-induced killer cell treatment plus regular treatment and follow up

Outcomes

Primary Outcome Measures

Time to recurrence (TTR)

Secondary Outcome Measures

Overall survival (OS)
Progression Free Survival (PFS)
Laboratory findings
AEs and SAEs

Full Information

First Posted
October 7, 2008
Last Updated
April 13, 2016
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT00769106
Brief Title
Study of Cytokine-induced Killer Cell (CIK) Treatment in Patients After Resection of Liver Cancer
Acronym
HCC-CIK
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
February 2015
Overall Recruitment Status
Completed
Study Start Date
June 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
Study hypothesis: The recurrence rate of HCC patients after radical resection is about 60-70%. This study is based on the hypothesis that CIK treatment could decrease the recurrence rate by 15% to 20%. Abstract: 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. Study treatment: Patients in group A will receive 4 cycles of CIK treatments within 3 months after their liver resection. Patients in group B will have no anti-cancer therapy. Anti-virus and other supportive therapies are available in both groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
hepatocellular carcinoma, recurrent, cytokine-induced killer cell

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
B (control group)
Arm Type
No Intervention
Arm Description
regular treatment and follow up
Arm Title
A (CIK group)
Arm Type
Experimental
Arm Description
cytokine-induced killer cell treatment plus regular treatment and follow up
Intervention Type
Biological
Intervention Name(s)
cytokine-induced killer cell (CIK) treatment
Other Intervention Name(s)
CIK
Intervention Description
cytokine-induced killer cell treatment every two weeks, for 4 cycles
Primary Outcome Measure Information:
Title
Time to recurrence (TTR)
Time Frame
month
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Time Frame
month
Title
Progression Free Survival (PFS)
Time Frame
month
Title
Laboratory findings
Time Frame
every 3 months
Title
AEs and SAEs
Time Frame
monthly

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Male or female patients > 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 <= 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 ECOG PS of 0, or 1. Cirrhotic status of Child-Pugh class A only. The following laboratory parameters: Platelet count >= 70 x 109/L Hemoglobin >= 8.5 g/dL Albumin >= 3.5 g/dL Total bilirubin <= 25umol/L Alanine transaminase (ALT) and AST <= 2.5 x upper limit of normal Serum creatinine <= 1.5 x the upper limit of normal Prothrombin time (PT) <= 3 seconds above control. 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 (> grade 2 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-qing Li, M.D.
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China

12. IPD Sharing Statement

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Study of Cytokine-induced Killer Cell (CIK) Treatment in Patients After Resection of Liver Cancer

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