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Efficacy and Safety of Immuncell-LC Group and Non-Treatment Group in Hepatocelluar Carcinoma Patients
This study is enrolling participants by invitation only.
First Received: June 17, 2008   Last Updated: November 3, 2008   History of Changes
Sponsored by: Innocell Corporation
Information provided by: Innocell Corporation
ClinicalTrials.gov Identifier: NCT00699816
  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 III

MedlinePlus related topics: Surgery
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Innocell 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 ]

Estimated Enrollment: 160
Study Start Date: July 2008
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
2: No Intervention
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 100ml/1 bag including lymphocyte 109~2 1010 within 1 hour. Drops can be increase or decrease by patient's condition.

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

Locations
Korea, Republic of, Seoul
Seoul National University Hospital
28. Yeongun-dong, Jongro-gu, Seoul, Seoul, Korea, Republic of, 110-744
Samsung Medical Center
50, Ilwon-dong, Gangnam-gu, Seoul, Seoul, Korea, Republic of, 135-710
Seoul Asan Medical center
Pungnab2-dong, Songpa-gu, Seoul, Seoul, Korea, Republic of, 138-736
Korea University Ansan Hospital
Gojan1-dong, Danwon-gu, Ansan-si, Kyoungi-do, Seoul, Seoul, Korea, Republic of, 425-707
Sponsors and Collaborators
Innocell Corporation
  More Information

Publications:
Responsible Party: Innocell ( Namsu, Kim )
Study ID Numbers: IIC-I01
Study First Received: June 17, 2008
Last Updated: November 3, 2008
ClinicalTrials.gov Identifier: NCT00699816     History of Changes
Health Authority: Korea: Food and Drug Administration

Study placed in the following topic categories:
Liver Neoplasms
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular
Gastrointestinal Neoplasms
Hepatocellular Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

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

ClinicalTrials.gov processed this record on May 07, 2009