CIK Treatment for HCC Patient Underwent Radical Resection

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Sun Yat-sen University
Sponsor:
Information provided by (Responsible Party):
LI Sheng-ping, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01749865
First received: December 12, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

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

  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 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
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: NCT01749865

Locations
China, Guangdong
Immunotherapy Recruiting
Guangzhou, Guangdong, China, 510060
Contact: LI XU, M.D.    862087343582    daughsea@hotmail.com   
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
ClinicalTrials.gov 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
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on October 01, 2014