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

This study is currently recruiting participants.
Verified May 2013 by Sun Yat-sen University
Information provided by (Responsible Party):
LI Sheng-ping, Sun Yat-sen University Identifier:
First received: October 7, 2008
Last updated: May 29, 2013
Last verified: May 2013

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Time to recurrence (TTR) [ Time Frame: month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival (OS) [ Time Frame: month ] [ Designated as safety issue: No ]
  • Progression Free Survival (PFS) [ Time Frame: month ] [ Designated as safety issue: No ]
  • Laboratory findings [ Time Frame: every 3 months ] [ Designated as safety issue: Yes ]
  • AEs and SAEs [ Time Frame: monthly ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: June 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: B
regular treatment
Experimental: A
cytokine-induced killer cell treatment plus regular treatment
Biological: cytokine-induced killer cell (CIK) treatment
cytokine-induced killer cell treatment every two weeks, for 4 cycles
Other Name: CIK


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its identifier: NCT00769106

Contact: Li Xu, M.D. 86-20-87343582

China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Li Xu, M.D.    86-20-87343582   
Principal Investigator: Sheng-ping Li, M.D.         
Sponsors and Collaborators
Sun Yat-sen University
Principal Investigator: Jin-qing Li, M.D. Sun Yat-sen University
  More Information

No publications provided

Responsible Party: LI Sheng-ping, Professor, Sun Yat-sen University Identifier: NCT00769106     History of Changes
Other Study ID Numbers: SunYat-senU 5010
Study First Received: October 7, 2008
Last Updated: May 29, 2013
Health Authority: China: Ministry of Health

Keywords provided by 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 processed this record on April 16, 2014