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: December 14, 2012
Last verified: December 2012
  Purpose

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


Condition Intervention Phase
Hepatocellular Carcinoma
Drug: activated T lymphocyte (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 'INNOCELL 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:
  • Radiological test should be operated by dynamic CT (using 64 cut), dynamic MRI or by angiography. [ Time Frame: Every 3months from the baseline ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall survival, cause-specific survival, changes of AFP, AST and ALT figures from baseline to the last observation date. [ Time Frame: Every 3months from the baseline ] [ Designated as safety issue: Yes ]

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
No Intervention: 2
Patient had curative resection for hepatocellular carcinoma before 12 weeks of applying this test and his (her) tumor's removal should be perfectly confirmed at least 4 weeks after the resection. Patient agrees on written consent for clinical trial Take needed medical examinations by the clinical trial plan Analyze whether patient is appropriate for this clinical trial or not Randomly allocate appropriate patients to'Immuncell-LC' group and'non-treatment' group.
Drug: activated T lymphocyte (Immuncell-LC)
Per 60kg For adult's average weight, injection a drop of test drug in a vein 200ml/1 bag including lymphocyte 109~2 1010 within 1 hour. Drops can be increase or decrease by patient's condition.
Other Name: Immuncell-LC

  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 Ccount 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Last Updated: December 14, 2012
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 October 23, 2014