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Efficacy and Safety of 'Immuncell-LC Group' and 'Non-treatment Group' in Nexavar Treated Patients for Advanced HCC

Sponsor
GC Cell Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT01897610
Collaborator
(none)
40
Enrollment
4
Locations
2
Arms
43.1
Duration (Months)
10
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

"Immuncell-LC" in aspects of therapeutic efficacy and safety when administered with Nexavar to advanced Hepatocellular carcinoma patients when compared with the control group who did not receive administration of the drug.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

  • primary outcome Compare clinical efficacy of group treated with cell therapeutic Immuncell-LC evaluated by progression free survival with that of untreated group

  • secondary outcome compare clinical efficacy of group treated with Immuncell-LC, a drug for treating advanced hepatocellular carcinoma evaluated by overall survival, disease control rate, changes of Alpha Feto Protein(AFP) figures from baseline to the last observation date and that of untreated group and evaluate adverse reactions, clinical pathological tests and its safety.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized, Open-label and Multi-center Clinical Trial to Evaluate the Efficacy and Safety of 'Immuncell-LC Group' and 'Non-treatment Group' in Nexavar Treated Patients for Advanced Hepatocellular Carcinoma
Study Start Date :
Dec 1, 2013
Actual Primary Completion Date :
Jul 1, 2017
Actual Study Completion Date :
Jul 4, 2017

Arms and Interventions

Arm Intervention/Treatment
No Intervention: control group

The study subjects randomly assigned to the control group is given Nexavar chemotherapy according to the clinical test plans.
Experimental: Immuncell-LC group

The study subjects assigned to the test group blood is drawn before minimum 2 weeks in order to manufacture the test drug. Test group is compared its progression free survival rate after baseline by administering Nexavar chemotherapy same as control group with Immuncell-LC (10 times).

Drug: Immuncell-LC
intravenous dripping of 200ml(10^9~2x10^10 lymphocytes/60kg adult) for 1 hour
Other Names:
  • Activated T lymphocyte

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To assess progression-free survival (PFS) [up to 2 years]

      CT, PET-CT, MRI

    Secondary Outcome Measures

    1. To assess the overall survival (OS) [up to 2 years]

    2. To evaluate the Disease control rate [up to 2 years]

      to determine response rate (CR, PR, SD rate) from the baseline to the late observation date using mRECIST

    3. To assess the changes of Alpha Feto Protein(AFP)figures from baseline to the last observation date [up to 2 years]

      analysing the changes of AFP before and after combination Nexavar plus Immuncell-LC

    4. Number of participants with adverse events [up to 2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients who have consented to the study by providing signature of self, guardian or legal representative

    • The patient is more than 20 and less than 80 years old

    • The patient is diagnosed as hepatocellular carcinoma by pathological/radiological test and in the stage of III or IV

    • Child-Pugh Score should be A

    • ECOG Performance Status (ECOG-PS) is less than 2 or equal to

    • Patients who receiving or ready for Nexavar treatment

    • Patients who satisfy the following conditions of the blood test and kidney function test

    • Absolute granulocyte count is bigger than 1,000/µL

    • Hemoglobin is bigger than 8.5 g/dL

    • Platelet count is bigger than 5x10^10/L

    • Blood Urea Nitrogen(BUN) or Creatinine 1.5xupper normal limit

    Exclusion Criteria:

    • Patients who are immune deficient or have a history of auto-immune diseases (Ex. Rheumatoid Arthritism, Systemic Lupus Erythematosus, Vasculitis, Multiple sclerosis, Adolescent Insulin-Dependent Diabetes Mellitus, etc.)

    • Patients who have a history of malignant tumors in the recent 5 years prior to the study with the exception of basal cell carcinoma, local prostate cancer, and cervical cancer, liver cancer.

    • Patients who had anti-cancer medication before the study with the exception of Nexavar

    • Patients who has serious dysfunction in other organs by sub-investigator's opinion

    • Patients has serious allergic-history by sub-investigator's opinion

    • Patients has serious mental disease sub-investigator's opinion

    • Pregnant women, nursing mother of having intention of being pregnant during the study

    • Patients who participated in other clinical trial within 4 weeks before this study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Inha University Hospital Incheon Korea, Republic of 400-711
    2 Yonsei University Health System Seoul Korea, Republic of 120-752
    3 Korea University Anam Hospital Seoul Korea, Republic of 136-750
    4 The Catholic University of Korea, Seoul ST. Mary's Hospital Seoul Korea, Republic of 137-701

    Sponsors and Collaborators

    • GC Cell Corporation

    Investigators

    • Principal Investigator: Soon Ho Um, MD, PhD, Korea University Anam Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    GC Cell Corporation
    ClinicalTrials.gov Identifier:
    NCT01897610
    Other Study ID Numbers:
    • ILC-IIT-04
    First Posted:
    Jul 12, 2013
    Last Update Posted:
    Sep 27, 2017
    Last Verified:
    Mar 1, 2016
    Keywords provided by GC Cell Corporation
    Immuncell-LC, advanced hepatocellular carcinoma
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Hepatocellular

    Study Results

    No Results Posted as of Sep 27, 2017