Long Term Follow-Up Study of Immuncell-LC Group and Non-Treatment Group in Hepatocellular Carcinoma Patients.
Overview
To observation that long term follow-up study of 'Immuncell-LC groups' and 'Non-treatment groups' in patient undergo curative resection (PEIT, RFA or Operation) for hepatocellular carcinoma in Korea
Full Title of Study: “Long Term Study of ‘Immuncell-LC Groups’ and ‘Non-treatment Groups’ in Patient Undergo Curative Resection (PEIT, Radiofrequency Ablation [RFA] or Operation) for Hepatocellular Carcinoma in Korea”
Study Type
- Study Type: Observational [Patient Registry]
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: January 2016
Arms, Groups and Cohorts
- Non-treatment Group
- Patients who were in non-treatment group in phase 3 clinical trial IIC-I01(NCT00699816).
- Immuncell-LC Group
- Patients who were in Immuncell-LC group in phase 3 clinical trial IIC-I01(NCT00699816).
Clinical Trial Outcome Measures
Primary Measures
- To evaluate recurrence-free survival
- Time Frame: up to 3 years
- Radiological test should be operated by dynamic CT(using 64 cut), dynamic MRI or by angiography.
Secondary Measures
- To determine the response rate to evaluate overall survival and cause specific survival and changes of Alpha feto protein (AFP) figures from baseline to the last observation date.
- Time Frame: up to 3 years
Participating in This Clinical Trial
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. – Patients of participated in the(ClinicalTrials.gov Identifier:NCT00699816)clinical trial. Exclusion Criteria:
- Patient who is incongruent to this clinical trial by sub-investigator's opinion.
Gender Eligibility: All
Minimum Age: 20 Years
Maximum Age: 80 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- GC Cell Corporation
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Jung Hwan Yoon, MD, Principal Investigator, Seoul National University Hospital
- Joon Hyeok Lee, MD, Principal Investigator, Samsung Medical Center
- Young-Suk Lim, MD, Principal Investigator, Asan Medical Center
- Tae Gin Song, MD, Principal Investigator, Korea University Ansan Hospital
- Jong Eun Yeon, MD, Principal Investigator, Korea University Guro Hospital
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