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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Green Cross Cell Corporation
ClinicalTrials.gov Identifier:
NCT00699816
First received: June 17, 2008
Last updated: August 23, 2015
Last verified: August 2015
  Purpose
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

Condition Intervention Phase
Hepatocellular Carcinoma
Biological: Immuncell-LC
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Green Cross Cell Corporation:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
    RFS was measured from the date of randomization to the first recurrence or to death from any cause.

  • 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) ] [ Designated as safety issue: Yes ]
    RFS rate was measured from the date of randomization to the first recurrence or to death from any cause.


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
    Overall survival was measured from the date of randomization until death from any cause.

  • 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) ] [ Designated as safety issue: Yes ]
    Cancer-specific survival was measured from the date of randomization until death resulting from HCC.

  • 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) ] [ Designated as safety issue: Yes ]
    Overall survival rate was measured from the date of randomization until death from any cause.

  • 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) ] [ Designated as safety issue: Yes ]
    Cancer-specific survival rate was measured from the date of randomization until death resulting from HCC.


Enrollment: 230
Study Start Date: July 2008
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
adjuvant adoptive immune therapy using a CIK cell agent
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

Detailed Description:
Multicenter, randomized, open-labeled phase 3 clinical trial.
  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00699816

Locations
Korea, Republic of
Korea University Guro Hospital
Seoul, Guro 2-Dong, Guro-Gu, Korea, Republic of, 152-703
Samsung Medical Center
Seoul, Ilwon-dong/Gangnam-gu, Korea, Republic of, 135-710
Korea University Ansan Hospital
Gojan1-dong, Danwon-gu, Ansan-si, Kyoungi-do, Seoul, Seoul, Korea, Republic of, 425-707
Seoul Asan Medical center
Pungnab2-dong, Songpa-gu, Seoul, Seoul, Korea, Republic of, 138-736
Seoul National University Hospital
Seoul, Yeongun-dong/Jongro-gu, Korea, Republic of, 110-744
Sponsors and Collaborators
Green Cross Cell Corporation
Investigators
Principal Investigator: Jung Hwan Yoon, MD Seoul National University Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Green Cross Cell Corporation
ClinicalTrials.gov Identifier: NCT00699816     History of Changes
Other Study ID Numbers: IIC-I01 
Study First Received: June 17, 2008
Results First Received: June 18, 2015
Last Updated: August 23, 2015
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on February 04, 2016