This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

CIK Treatment for HCC Patient Underwent Radical Resection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LI Sheng-ping, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01749865
First received: December 12, 2012
Last updated: April 13, 2016
Last verified: April 2016
  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
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

Further study details as provided by LI Sheng-ping, Sun Yat-sen University:

Primary Outcome Measures:
  • Time to recurrence [ Time Frame: 5-year ]
    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 ]
    Disease Free Survival


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


Enrollment: 200
Study Start Date: October 2008
Study Completion Date: December 2014
Primary Completion Date: September 2014 (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 to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
  More Information

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: 2007043-HCC012
Study First Received: December 12, 2012
Last Updated: April 13, 2016

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 June 26, 2017