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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00769106
Recruitment Status : Completed
First Posted : October 8, 2008
Last Update Posted : April 14, 2016
Information provided by (Responsible Party):
LI Sheng-ping, Sun Yat-sen University

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%.


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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Biological: cytokine-induced killer cell (CIK) treatment Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study of Cytokine-induced Killer Cell (CIK) Treatment in Patients With Hepatocellular Carcinoma Who Underwent Radical Resection.
Study Start Date : June 2008
Actual Primary Completion Date : September 2014
Actual Study Completion Date : December 2014

Arm Intervention/treatment
No Intervention: B (control group)
regular treatment and follow up
Experimental: A (CIK group)
cytokine-induced killer cell treatment plus regular treatment and follow up
Biological: cytokine-induced killer cell (CIK) treatment
cytokine-induced killer cell treatment every two weeks, for 4 cycles
Other Name: CIK

Primary Outcome Measures :
  1. Time to recurrence (TTR) [ Time Frame: month ]

Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: month ]
  2. Progression Free Survival (PFS) [ Time Frame: month ]
  3. Laboratory findings [ Time Frame: every 3 months ]
  4. AEs and SAEs [ Time Frame: monthly ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00769106

China, Guangdong
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Principal Investigator: Jin-qing Li, M.D. Sun Yat-sen University

Responsible Party: LI Sheng-ping, Professor, Sun Yat-sen University Identifier: NCT00769106     History of Changes
Other Study ID Numbers: SunYat-senU 5010
First Posted: October 8, 2008    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: February 2015

Keywords provided by LI Sheng-ping, Sun Yat-sen University:
hepatocellular carcinoma
cytokine-induced killer cell

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases