Hepatocellular CarcinomaImmuncell-LCNCT01890291
Long Term Follow-Up Study of Immuncell-LC Group and Non-Treatment Group in Hepatocellular Carcinoma Patients.
An observational study of Hepatocellular Carcinoma, run by GC Cell Corporation at 5 sites in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma
- How many people
- 162 participants
- Where
- 5 sitesSouth Korea
- Study dates
- Jun 2013to Feb 2016
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patient who is incongruent to this clinical trial by sub-investigator's opinion.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Seoul National Hospital
Seoul, 110-744
Samsung Medical Center
Seoul, 135-710
Asan Medical Center
Seoul, 138-736
Korea University Guro Hospital
Seoul, 152-703
Korea University Ansan Hospital
Seoul, 425-707
About this study
Official title: 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
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
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate recurrence-free survival
Radiological test should be operated by dynamic CT(using 64 cut), dynamic MRI or by angiography.
Measured: 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.
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionJan 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 162 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- GC Cell Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jung Hwan Yoon, MD, Principal investigator, Seoul National University HospitalJoon Hyeok Lee, MD, Principal investigator, Samsung Medical CenterYoung-Suk Lim, MD, Principal investigator, Asan Medical CenterTae Gin Song, MD, Principal investigator, Korea University Ansan HospitalJong Eun Yeon, MD, Principal investigator, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01890291
- Sponsor's protocol ID
- IIC-I02
- Acronym
- Immuncell-LC
- Status last verified
- Jun 2023
- First submitted
- 24 Jun 2013
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01890291
- Acronym / sponsor ID
- Immuncell-LC / IIC-I02
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Immuncell-LC, Hepatocellular carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- GC Cell CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 1 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Patient who is incongruent to this clinical trial by sub-investigator's opinion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by GC Cell Corporation at 5 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate recurrence-free survival (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2023.