Long Term Follow-Up Study of Immuncell-LC Group and Non-Treatment Group in Hepatocellular Carcinoma Patients.

NCT01890291 | Completed

• 1 other identifier: IIC-I02
• Study Type: observational
• Target: 162
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Hepatocellular Carcinoma

Keywords

Immuncell-LC, Hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

• To evaluate recurrence-free survival

  Radiological test should be operated by dynamic CT(using 64 cut), dynamic MRI or by angiography.

  up to 3 years

Secondary Outcomes (1)

• 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.

  up to 3 years

Study Arms (2)

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).

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This long term follow-UP study is observation about the Immuncell-LC Groups' and 'Non-treatment Groups' in patient undergo curative resection (PEIT, RFA or Operation) for Hepatocelluar Carcinoma in Korea.

You may qualify if:

• 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.

You may not qualify if:

• Patient who is incongruent to this clinical trial by sub-investigator's opinion.

Sponsors & Collaborators

• GC Cell Corporation: lead

Study Sites (5)

Seoul National Hospital

Seoul, 110-744, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

Korea University Guro Hospital

Seoul, 152-703, South Korea

Location

Korea University Ansan Hospital

Seoul, 425-707, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Jung Hwan Yoon, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

• Joon Hyeok Lee, MD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

• Young-Suk Lim, MD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

• Tae Gin Song, MD

  Korea University Ansan Hospital

  PRINCIPAL INVESTIGATOR

• Jong Eun Yeon, MD

  Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2013
• First Posted: July 1, 2013
• Study Start: June 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: February 1, 2016
• Last Updated: June 26, 2023

Record last verified: 2023-06

Locations

KR (5)