CIK Treatment for HCC Patient Underwent Radical Resection

April 13, 2016 updated by: LI Sheng-ping, Sun Yat-sen University

A Randomized Controlled Study of Cytokine-induced Killer Cell (CIK) Treatment in Patients With Hepatocellular Carcinoma Who Underwent Radical Resection

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Immunotherapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A, CIK
Biological/Vaccine: Cytokine-Induced Killer Cells
Biological: Cytokine-Induced Killer Cells
Cytokine-Induced Killer Cells treatment for 4 cycles
Other Names:
  • CIK
No Intervention: B, CONTROL
Regular follow up with no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Free Survival
Time Frame: 5 year
Disease Free Survival
5 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

December 12, 2012

First Submitted That Met QC Criteria

December 12, 2012

First Posted (Estimate)

December 17, 2012

Study Record Updates

Last Update Posted (Estimate)

April 14, 2016

Last Update Submitted That Met QC Criteria

April 13, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007043-HCC012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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