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Sponsored by: |
Innocell Corporation |
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Information provided by: | Innocell Corporation |
ClinicalTrials.gov Identifier: | NCT00699816 |
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 |
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Hepatocellular Carcinoma |
Drug: activated T lymphocyte (Immuncell-LC) |
Phase III |
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 |
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 |
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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.
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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.
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Ages Eligible for Study: | 20 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patient should meet below conditions by blood test, kidney and liver function test
Exclusion Criteria:
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 |
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 |
Liver Neoplasms Liver Diseases Digestive System Diseases Digestive System Neoplasms Carcinoma, Hepatocellular |
Gastrointestinal Neoplasms Hepatocellular Carcinoma Adenocarcinoma Neoplasms, Glandular and Epithelial Carcinoma |
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 |