CIK Treatment for HCC Patient Underwent Radical Resection

This study is currently recruiting participants.
Verified December 2012 by Sun Yat-sen University
Information provided by (Responsible Party):
LI Sheng-ping, Sun Yat-sen University Identifier:
First received: December 12, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted

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.

Condition Intervention Phase
Carcinoma, Hepatocellular
Biological: Cytokine-Induced Killer Cells
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 [ Time Frame: 5-year ] [ Designated as safety issue: No ]
    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 [ Time Frame: 5 year ] [ Designated as safety issue: No ]
    Disease Free Survival

Other Outcome Measures:
  • Adverse Events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    To evaluate safety of CIK treatment as an adjuvant therapy in patients with hepatocellular carcinoma (HCC) who underwent radical resection.

Estimated Enrollment: 200
Study Start Date: October 2008
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A, CIK
Biological/Vaccine: Cytokine-Induced Killer Cells
Biological: Cytokine-Induced Killer Cells
Cytokine-Induced Killer Cells treatment for 4 cycles
Other Name: CIK
No Intervention: B, CONTROL
Regular follow up with no intervention


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
Please refer to this study by its identifier: NCT01749865

China, Guangdong
Immunotherapy Recruiting
Guangzhou, Guangdong, China, 510060
Contact: LI XU, M.D.    862087343582   
Sub-Investigator: LI XU, M.D.         
Sponsors and Collaborators
Sun Yat-sen University
  More Information

No publications provided

Responsible Party: LI Sheng-ping, Vice director, Sun Yat-sen University Cancer Center, Sun Yat-sen University Identifier: NCT01749865     History of Changes
Other Study ID Numbers: NCT00769106
Study First Received: December 12, 2012
Last Updated: December 12, 2012
Health Authority: Sun Yat-sen University: China

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 17, 2014