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

Last updated: June 22, 2023
Sponsor: GC Cell Corporation
Overall Status: Completed

Phase

3

Condition

Cancer/tumors

Digestive System Neoplasms

Carcinoma

Treatment

Immuncell-LC

Clinical Study ID

NCT00699816
IIC-I01
  • Ages 20-80
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Prior to the test, patient is fully explained about the purpose/ contents andcharacteristics of the testing medication, and the patient him(her)self, the guardianor 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/ radiologicaltest 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, dynamicMRI 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 totallyremoved by curative resection (PEIT, RFA or operation) in 12 weeks. (based on theagreement date for written consent) The tumor's removal should be perfectly confirmedby pathological or radiological test with the mentioned method in 3) at least 4 weekslater.
  • ECOG Performance status (ECOG-PS) is less than 1 or equal to (refer to the exhibit 8)
  • 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

Exclusion

Exclusion Criteria:

  • 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 byimmunotherapy) or auto-immune disease (ex. arthritis rheumatism, Burger's disease,multiple sclerosis and adolescent-occurred insulin dependent diabetes)
  • Diagnosed as an immune deficiency patient
  • Patient who has disease history of malignant tumor within 5 years before this clinicaltrial. (except for skin cancer, local prostate cancer or carcinoma in situ of theuterine 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 theclinical test
  • Patient who participated in other clinical trial within 4 weeks before this clinicaltrial
  • Patient who is incongruent to this clinical trial by sub- investigator's opinion.

Study Design

Total Participants: 230
Treatment Group(s): 1
Primary Treatment: Immuncell-LC
Phase: 3
Study Start date:
July 01, 2008
Estimated Completion Date:
November 30, 2012

Study Description

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

Connect with a study center

  • Korea University Ansan Hospital

    Ansan si, Gojan1-dong/Danwon-gu 425-707
    Korea, Republic of

    Site Not Available

  • Korea University Guro Hospital

    Seoul, Guro 2-Dong, Guro-Gu 152-703
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, Ilwon-dong/Gangnam-gu 135-710
    Korea, Republic of

    Site Not Available

  • Seoul Asan Medical center

    Seoul, Pungnab2-dong/Songpa-gu 138-736
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    28. Yeongun-dong, Jongro-gu, Seoul, Seoul 110-744
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    50, Ilwon-dong, Gangnam-gu, Seoul, Seoul 135-710
    Korea, Republic of

    Site Not Available

  • Korea University Ansan Hospital

    Gojan1-dong, Danwon-gu, Ansan-si, Kyoungi-do, Seoul, Seoul 425-707
    Korea, Republic of

    Site Not Available

  • Seoul Asan Medical center

    Pungnab2-dong, Songpa-gu, Seoul, Seoul 138-736
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, Yeongun-dong/Jongro-gu 110-744
    Korea, Republic of

    Site Not Available

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