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CIK Treatment for HCC Patient Underwent Radical Resection

Sponsor
Sun Yat-sen University (Other)
Overall Status
Completed
CT.gov ID
NCT01749865
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
74
Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Biological: Cytokine-Induced Killer Cells
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Study Start Date :
Oct 1, 2008
Actual Primary Completion Date :
Sep 1, 2014
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Time to recurrence [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

    1. Disease Free Survival [5 year]

      Disease Free Survival

    Other Outcome Measures

    1. Adverse Events [5 years]

      To evaluate safety of CIK treatment as an adjuvant therapy in patients with hepatocellular carcinoma (HCC) who underwent radical resection.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Immunotherapy Guangzhou Guangdong China 510060

    Sponsors and Collaborators

    • Sun Yat-sen University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    LI Sheng-ping, Vice director, Sun Yat-sen University Cancer Center, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT01749865
    Other Study ID Numbers:
    • 2007043-HCC012
    First Posted:
    Dec 17, 2012
    Last Update Posted:
    Apr 14, 2016
    Last Verified:
    Apr 1, 2016
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Hepatocellular

    Study Results

    No Results Posted as of Apr 14, 2016