Randomized, Open-label, Multi-center and Phase 3 Clinical Trial to Compare the Efficacy and Safety of 'INNOCELL Immuncell-LC Group' and 'Non-treatment Group' in Patient Undergone Curative Resection(PEIT, RFA or Operation) for Hepatocellular Carcinoma in Korea
- 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
- 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 Ccount 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
- 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
- Patient who participated in other clinical trial within 4 weeks before this clinical
- Patient who is incongruent to this clinical trial by sub- investigator's opinion.