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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Sun Yat-sen University
Sponsor:
Information provided by (Responsible Party):
LI Sheng-ping, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00769106
First received: October 7, 2008
Last updated: May 29, 2013
Last verified: May 2013

October 7, 2008
May 29, 2013
June 2008
December 2013   (final data collection date for primary outcome measure)
Time to recurrence (TTR) [ Time Frame: month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00769106 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study of Cytokine-induced Killer Cell (CIK) Treatment in Patients After Resection of Liver Cancer
A Randomized Controlled Study of Cytokine-induced Killer Cell (CIK) Treatment in Patients With Hepatocellular Carcinoma Who Underwent Radical Resection.

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatocellular Carcinoma
Biological: cytokine-induced killer cell (CIK) treatment
cytokine-induced killer cell treatment every two weeks, for 4 cycles
Other Name: CIK
  • No Intervention: B
    regular treatment
  • Experimental: A
    cytokine-induced killer cell treatment plus regular treatment
    Intervention: Biological: cytokine-induced killer cell (CIK) treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2013
December 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Li Xu, M.D. 86-20-87343582 xuli@sysucc.org.cn
China
 
NCT00769106
SunYat-senU 5010
Yes
LI Sheng-ping, Sun Yat-sen University
Sun Yat-sen University
Not Provided
Principal Investigator: Jin-qing Li, M.D. Sun Yat-sen University
Sun Yat-sen University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP