Phase
Condition
Cancer/tumors
Digestive System Neoplasms
Carcinoma
Treatment
Immuncell-LC
Clinical Study ID
Ages 20-80 All Genders
Study Summary
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
Study Description
Connect with a study center
Korea University Ansan Hospital
Ansan si, Gojan1-dong/Danwon-gu 425-707
Korea, Republic ofSite Not Available
Korea University Guro Hospital
Seoul, Guro 2-Dong, Guro-Gu 152-703
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul, Ilwon-dong/Gangnam-gu 135-710
Korea, Republic ofSite Not Available
Seoul Asan Medical center
Seoul, Pungnab2-dong/Songpa-gu 138-736
Korea, Republic ofSite Not Available
Seoul National University Hospital
28. Yeongun-dong, Jongro-gu, Seoul, Seoul 110-744
Korea, Republic ofSite Not Available
Samsung Medical Center
50, Ilwon-dong, Gangnam-gu, Seoul, Seoul 135-710
Korea, Republic ofSite Not Available
Korea University Ansan Hospital
Gojan1-dong, Danwon-gu, Ansan-si, Kyoungi-do, Seoul, Seoul 425-707
Korea, Republic ofSite Not Available
Seoul Asan Medical center
Pungnab2-dong, Songpa-gu, Seoul, Seoul 138-736
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, Yeongun-dong/Jongro-gu 110-744
Korea, Republic ofSite Not Available

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