Efficacy and Safety of Immuncell-LC Group and Non-treatment Group in Hepatocelluar Carcinoma Patients
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: Immuncell-LC
Intervention description: Activated T lymphocyte
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 230.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No

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 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.

          -  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)

          -  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 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 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

          -  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.