Journal of Clinical Immunology

, Volume 34, Issue 2, pp 194–203 | Cite as

A randomized phase II study of autologous cytokine-induced killer cells in treatment of hepatocelluar carcinoma

  • Xiaozhou Yu
  • Hua Zhao
  • Liang Liu
  • Shui Cao
  • Baozhu Ren
  • Naining Zhang
  • Xiumei An
  • Jinpu Yu
  • Hui Li
  • Xiubao Ren
Original Research
First Online:
Received:
Accepted:

Abstract

Purpose

This prospective study aims to explore the benefit of cytokine-induced killer cell (CIK) treatment in hepatocellular carcinoma patients, which has not yet been thoroughly studied before.

Methods

From January 2004 to May 2009, 132 patients who were initially diagnosed with hepatocellular carcinoma of Barcelona Clinic Liver Cancer (BCLC) stage A, B or C, Child–Pugh scores of A or B and without prior treatment were enrolled in the study. Patients were randomly assigned to either arm 1 (n = 66) to receive CIK treatment plus standard treatment, or arm 2 (n = 66) to receive standard treatment only. The primary end point was overall survival (OS) and the secondary endpoint was progression-free survival as evaluated by Kaplan–Meier analyses and treatment hazard ratios with the Cox proportional hazards model.

Results

The 1-year (OS: 74.2 % vs. 50.0 %, 95 % CI: 63.6–84.8 % vs. 37.8–62.2, p = 0.002), 2-year (OS: 53.0 % vs. 30.3 %, 95 % CI: 40.8–65.2 % vs. 19.1–41.5 %, p = 0.002), 3-year (OS: 42.4 % vs. 24.2 %, 95 % CI: 30.4–54.4 % vs. 13.8–34.6 %, p = 0.005) and median overall and progression-free survivals of arm 1 patients were significantly higher than those of arm 2. Therefore, in patients who are not suitable for surgery, significant benefit is obtained from CIK treatment. The main adverse effects of CIK included fever, allergy and headache pain.

Conclusions

Hepatocellular carcinoma patients who were not suitable for surgery demonstrate prolonged overall and progression-free survival from CIK treatment.

Keywords

Cytokine-induced killer cells hepatocellular carcinoma immunotherapy trans-arterial chemoembolization 
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Notes

Acknowledgments

We thank Dr. Shizhen Emily Wang, from the Division of Tumor Cell Biology, Beckman Research Institute of City of Hope for providing help and assistance with this study. This project was supported by grants from the National Basic Research Program of China (973 program) (No. 2012CB9333004) and National Natural Science Funds (No. 81171983 and 30901754). The authors declare that they have no conflicts of interest.

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Copyright information

© Springer Science+Business Media New York 2013

Authors and Affiliations

  • Xiaozhou Yu
    • 1
    • 2
    • 3
  • Hua Zhao
    • 1
    • 2
    • 3
  • Liang Liu
    • 1
    • 2
    • 3
  • Shui Cao
    • 1
    • 2
    • 3
  • Baozhu Ren
    • 1
    • 2
    • 3
  • Naining Zhang
    • 1
    • 2
    • 3
  • Xiumei An
    • 1
    • 2
    • 3
  • Jinpu Yu
    • 1
    • 2
    • 3
  • Hui Li
    • 1
    • 2
    • 3
  • Xiubao Ren
    • 1
    • 2
    • 3
  1. 1.Department of ImmunologyTianjin Medical University Cancer Institute & HospitalTianjinChina
  2. 2.National Clinical Research Center of CancerTianjinChina
  3. 3.Key Laboratory of Cancer Immunology and BiotherapyTianjinChina

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