Efficacy and Safety of Immuncell-LC Group and Non-treatment Group in Hepatocelluar Carcinoma Patients

June 22, 2023 updated by: GC Cell Corporation

Randomized, Open-label, Multi-center and Phase 3 Clinical Trial to Compare the Efficacy and Safety of 'Green Cross CELL Immuncell-LC Group' and 'Non-treatment Group' in Patient Undergone Curative Resection(PEIT, RFA or Operation) for Hepatocellular Carcinoma in Korea

To prove that the efficacy and safety of 'Green Cross CELL* Immuncell-LC group' is superior to 'non-treatment group(Control group)' in patient undergone curative resection(PEIT, RFA or operation) for hepatocellular carcinoma in Korea

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Multicenter, randomized, open-labeled phase 3 clinical trial.

Study Type

Interventional

Enrollment (Actual)

230

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

  • Korea, Republic of
    • Gojan1-dong/Danwon-gu
      • Ansan si, Gojan1-dong/Danwon-gu, Korea, Republic of, 425-707
        • Korea University Ansan Hospital
    • Guro 2-Dong, Guro-Gu
      • Seoul, Guro 2-Dong, Guro-Gu, Korea, Republic of, 152-703
        • Korea University Guro Hospital
    • Ilwon-dong/Gangnam-gu
      • Seoul, Ilwon-dong/Gangnam-gu, Korea, Republic of, 135-710
        • Samsung Medical Center
    • Pungnab2-dong/Songpa-gu
      • Seoul, Pungnab2-dong/Songpa-gu, Korea, Republic of, 138-736
        • Seoul Asan Medical Center
    • Yeongun-dong/Jongro-gu
      • Seoul, Yeongun-dong/Jongro-gu, Korea, Republic of, 110-744
        • Seoul National University Hospital

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

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Prior to the test, patient is fully explained about the purpose/ contents and characteristics of the testing medication, and the patient him(her)self, the guardian or the legal representative signed on written consent.
  • The patient is more than 20 and less than 80 years old
  • The patient is diagnosed as hepatocellular carcinoma by pathological/ radiological test and he (she) is in the stage of I or II. (refer to the attached file 10). Hepatocellular carcinoma should be shown by radiological test; on dynamic CT, dynamic MRI or on angiography.
  • Child-Pugh Score should be less than 6 (refer to the attached file 7)
  • No matter how the patient has been treated before, his (her) tumor should be totally removed by curative resection (PEIT, RFA or operation) in 12 weeks. (based on the agreement date for written consent) The tumor's removal should be perfectly confirmed by pathological or radiological test with the mentioned method in 3) at least 4 weeks later.
  • ECOG Performance status (ECOG-PS) is less than 1 or equal to (refer to the exhibit 8)
  • Patient's remaining life-time should be expected at least more than 3 months.

  • Patient should meet below conditions by blood test, kidney and liver function test

    : Re-evaluation is possible during screening

  • Leukocyte count is bigger than (3 multiply 109/L)
  • Absolute Neutrophil Count (ANC) is bigger than or equal to 1,000/µL
  • Hemoglobin is bigger than or equal to 8.5 g/dL
  • Thrombocyte count is bigger than (5 multiply 1010/L)
  • BUN and serum Creatinine is less than or equal to 1.5 multiply normal upper-limit
  • No more disease abdominal extrahepatic transfer is confirmed by abdominal CT/ MRI

Exclusion Criteria:

  • Hepatocellular carcinoma has been transferred by pathological/ radiological test (Stage III or Stage IV, refer to the exhibit 10)
  • The carcinoma has been invaded to main portal vein or major branch hepatic vein
  • Child-Pugh score is over 6
  • Patient has serious problem with pulmonary function by sub- investigator's opinion
  • Patient who has disease history of immune deficiency (which can be worse by immunotherapy) or auto-immune disease (ex. arthritis rheumatism, Burger's disease, multiple sclerosis and adolescent-occurred insulin dependent diabetes)
  • Diagnosed as an immune deficiency patient
  • Patient who has disease history of malignant tumor within 5 years before this clinical trial. (except for skin cancer, local prostate cancer or carcinoma in situ of the uterine cervix
  • Patient who had anti-cancer medication before the clinical trial
  • Patient who has serious disease in other organs after tumor resection.
  • Patient has serious allergic-history by sub- investigator's opinion
  • Patient has serious mental disease by sub- investigator's opinion
  • Pregnant women, nursing mother or having intention of being pregnant during the clinical test
  • Patient who participated in other clinical trial within 4 weeks before this clinical trial
  • Patient who is incongruent to this clinical trial by sub- investigator's opinion.

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: Immunotherapy Group
Adjuvant adoptive immune therapy using a CIK cell agent(Immuncell-LC) 16 times(4 treatments at a frequency of once per week, followed by 4 treatments every 2 weeks, then 4 treatments every 4 weeks, and finally 4 treatments every 8 weeks.
Biological: Immuncell-LC
Activated T lymphocyte
No Intervention: Control Group
Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence Free Survival(RFS)
Time Frame: Every 3months from the baseline for 24 months and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)
RFS was measured from the date of randomization to the first recurrence or to death from any cause.
Every 3months from the baseline for 24 months and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)
Recurrence Free Survival(RFS) Rate
Time Frame: Every 3months from the baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)
RFS rate was measured from the date of randomization to the first recurrence or to death from any cause.
Every 3months from the baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival(OS)
Time Frame: Every 3months from the baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)
Overall survival was measured from the date of randomization until death from any cause.
Every 3months from the baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)
Cancer-specific Survivals
Time Frame: Every 3 months from baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)
Cancer-specific survival was measured from the date of randomization until death resulting from HCC.
Every 3 months from baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)
Overall Survival(OS) Rate
Time Frame: Every 3months from the baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)
Overall survival rate was measured from the date of randomization until death from any cause.
Every 3months from the baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)
Cancer-specific Survival Rate
Time Frame: Every 3 months from baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)
Cancer-specific survival rate was measured from the date of randomization until death resulting from HCC.
Every 3 months from baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)

Collaborators and Investigators

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

Sponsor

GC Cell Corporation

Investigators

  • Principal Investigator: Jung Hwan Yoon, MD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2008

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

June 17, 2008

First Submitted That Met QC Criteria

June 17, 2008

First Posted (Estimated)

June 18, 2008

Study Record Updates

Last Update Posted (Actual)

July 11, 2023

Last Update Submitted That Met QC Criteria

June 22, 2023

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIC-I01

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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