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
  Purpose

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.


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

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00769106

Contacts
Contact: Li Xu, M.D. 86-20-87343582 xuli@sysucc.org.cn

Locations
China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Li Xu, M.D.    86-20-87343582    xuli@sysucc.org.cn   
Principal Investigator: Sheng-ping Li, M.D.         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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
ClinicalTrials.gov 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
recurrent
cytokine-induced killer cell

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

ClinicalTrials.gov processed this record on September 16, 2014