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Hepatocellular CarcinomaPhase 3NCT00699816

Efficacy and Safety of Immuncell-LC Group and Non-treatment Group in Hepatocelluar Carcinoma Patients

A Phase 3 study testing Immuncell-LC in people with Hepatocellular Carcinoma, run by GC Cell Corporation at 5 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To prove that the efficacy and safety of 'Green Cross CELL* Immuncell-LC group' is superior to 'non-treatment group(Control group)' in patient undergone 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
What is being tested?
Immuncell-LC
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
230 participants
Where
5 sitesSouth Korea
Study dates
Jul 2008to Nov 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

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.
  • The patient is more than 20 and less than 80 years old
  • The patient is diagnosed as hepatocellular carcinoma by pathological/ radiological test and he (she) is in the stage of I or II. (refer to the attached file 10). Hepatocellular carcinoma should be shown by radiological test; on dynamic CT, dynamic MRI or on angiography.
  • Child-Pugh Score should be less than 6 (refer to the attached file 7)
  • No matter how the patient has been treated before, his (her) tumor should be totally removed by curative resection (PEIT, RFA or operation) in 12 weeks. (based on the agreement date for written consent) The tumor's removal should be perfectly confirmed by pathological or radiological test with the mentioned method in 3) at least 4 weeks later.
  • ECOG Performance status (ECOG-PS) is less than 1 or equal to (refer to the exhibit 8)
Show all 15Show fewer
  • Patient's remaining life-time should be expected at least more than 3 months.
  • Patient should meet below conditions by blood test, kidney and liver function test
  • : Re-evaluation is possible during screening
  • Leukocyte count is bigger than (3 multiply 109/L)
  • Absolute Neutrophil Count (ANC) is bigger than or equal to 1,000/µL
  • Hemoglobin is bigger than or equal to 8.5 g/dL
  • Thrombocyte count is bigger than (5 multiply 1010/L)
  • BUN and serum Creatinine is less than or equal to 1.5 multiply normal upper-limit
  • No more disease abdominal extrahepatic transfer is confirmed by abdominal CT/ MRI

Who cannot join

  • Hepatocellular carcinoma has been transferred by pathological/ radiological test (Stage III or Stage IV, refer to the exhibit 10)
  • The carcinoma has been invaded to main portal vein or major branch hepatic vein
  • Child-Pugh score is over 6
  • Patient has serious problem with pulmonary function by sub- investigator's opinion
  • Patient who has disease history of immune deficiency (which can be worse by immunotherapy) or auto-immune disease (ex. arthritis rheumatism, Burger's disease, multiple sclerosis and adolescent-occurred insulin dependent diabetes)
  • Diagnosed as an immune deficiency patient
Show all 14Show fewer
  • Patient who has disease history of malignant tumor within 5 years before this clinical trial. (except for skin cancer, local prostate cancer or carcinoma in situ of the uterine cervix
  • Patient who had anti-cancer medication before the clinical trial
  • Patient who has serious disease in other organs after tumor resection.
  • Patient has serious allergic-history by sub- investigator's opinion
  • Patient has serious mental disease by sub- investigator's opinion
  • Pregnant women, nursing mother or having intention of being pregnant during the clinical test
  • Patient who participated in other clinical trial within 4 weeks before this clinical trial
  • 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

  • Korea University Ansan Hospital

    Ansan-si, Gojan1-dong/Danwon-gu, 425-707

  • Korea University Guro Hospital

    Seoul, Guro 2-Dong, Guro-Gu, 152-703

  • Samsung Medical Center

    Seoul, Ilwon-dong/Gangnam-gu, 135-710

  • Seoul Asan Medical center

    Seoul, Pungnab2-dong/Songpa-gu, 138-736

  • Seoul National University Hospital

    Seoul, Yeongun-dong/Jongro-gu, 110-744

Other trials in South Korea

About this study

Official title: Randomized, Open-label, Multi-center and Phase 3 Clinical Trial to Compare the Efficacy and Safety of 'Green Cross CELL Immuncell-LC Group' and 'Non-treatment Group' in Patient Undergone Curative Resection(PEIT, RFA or Operation) for Hepatocellular Carcinoma in Korea

To prove that the efficacy and safety of 'Green Cross CELL* Immuncell-LC group' is superior to 'non-treatment group(Control group)' in patient undergone curative resection(PEIT, RFA or operation) for hepatocellular carcinoma in Korea

Read the detailed description

Multicenter, randomized, open-labeled phase 3 clinical trial.

Being tested
Immuncell-LC
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Immuncell-LCBiological

    Activated T lymphocyte

Study groups in NCT00699816
Study groupRoleWhat they receive
Immunotherapy GroupExperimentalAdjuvant adoptive immune therapy using a CIK cell agent(Immuncell-LC) 16 times(4 treatments at a frequency of once per week, followed by 4 treatments every 2 weeks, then 4 treatments every 4 weeks, and finally 4 treatments every 8 weeks.
Receives: Biological: Immuncell-LC
Control GroupNo interventionPatients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrence Free Survival(RFS)

    RFS was measured from the date of randomization to the first recurrence or to death from any cause.

    Measured: Every 3months from the baseline for 24 months and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)

  2. Recurrence Free Survival(RFS) Rate

    RFS rate was measured from the date of randomization to the first recurrence or to death from any cause.

    Measured: Every 3months from the baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)

Secondary outcomes (4)

  1. Overall Survival(OS)

    Overall survival was measured from the date of randomization until death from any cause.

    Measured: Every 3months from the baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)

  2. Cancer-specific Survivals

    Cancer-specific survival was measured from the date of randomization until death resulting from HCC.

    Measured: Every 3 months from baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)

  3. Overall Survival(OS) Rate

    Overall survival rate was measured from the date of randomization until death from any cause.

    Measured: Every 3months from the baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)

  4. Cancer-specific Survival Rate

    Cancer-specific survival rate was measured from the date of randomization until death resulting from HCC.

    Measured: Every 3 months from baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionNov 2012
  4. Study completionNov 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
230 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00699816
Sponsor's protocol ID
IIC-I01
Status last verified
Aug 2015
First submitted
17 Jun 2008
Last updated
11 Jul 2023
Data monitoring committee
No

Publications

  • Takayama T, Sekine T, Makuuchi M, Yamasaki S, Kosuge T, Yamamoto J, Shimada K, Sakamoto M, Hirohashi S, Ohashi Y, Kakizoe T. Adoptive immunotherapy to lower postsurgical recurrence rates of hepatocellular carcinoma: a randomised trial. Lancet. 2000 Sep 2;356(9232):802-7. doi: 10.1016/S0140-6736(00)02654-4.

    PubMed 11022927

  • Lee JH, Lee JH, Lim YS, Yeon JE, Song TJ, Yu SJ, Gwak GY, Kim KM, Kim YJ, Lee JW, Yoon JH. Adjuvant immunotherapy with autologous cytokine-induced killer cells for hepatocellular carcinoma. Gastroenterology. 2015 Jun;148(7):1383-91.e6. doi: 10.1053/j.gastro.2015.02.055. Epub 2015 Mar 4.

    PubMed 25747273

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Immuncell-LC in people with 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 15 inclusion and 14 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 11 Jul 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Recurrence Free Survival(RFS) (time frame: Every 3months from the baseline for 24 months and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00699816, which also lists 2 linked publications.

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 11 Jul 2023.

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