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CompletedNCT01890291Immuncell-LCUpdated Jun 26, 2023

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

An observational study in Hepatocellular Carcinoma, sponsored by GC Cell Corporation. Completed at 5 sites in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-06-26.

Sponsored by GC Cell Corporation · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
162
Ages
20 Years to 80 Years
Sex
All
01

Study 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

02

Conditions studied

  • Hepatocellular Carcinoma

Keywords

  • Immuncell-LC, Hepatocellular carcinoma
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 162 is close to the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

GC Cell Corporation is the lead sponsor of 15 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

  • Patient who is incongruent to this clinical trial by sub-investigator's opinion.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
162 participants (actual)
Target follow-up
3 Years
Patient registry
Yes

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).

06

What researchers measure

Primary outcomes

  1. To evaluate recurrence-free survival

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

    Time frame: 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.

    Time frame: up to 3 years

07

Study locations

5 sites
  • Seoul National Hospital
    Seoul, 110-744, Korea, Republic of
  • Samsung Medical Center
    Seoul, 135-710, Korea, Republic of
  • Asan Medical Center
    Seoul, 138-736, Korea, Republic of
  • Korea University Guro Hospital
    Seoul, 152-703, Korea, Republic of
  • Korea University Ansan Hospital
    Seoul, 425-707, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01890291
Lead sponsor
GC Cell Corporation
Responsible party
Sponsor
First posted
Jul 1, 2013
Start date
Jun 2013
Primary completion
Jan 2016
Completion
Feb 2016
Last update
Jun 26, 2023

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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