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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