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
Multicenter, randomized, open-labeled phase 3 clinical trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
230
Activated T lymphocyte
Korea University Ansan Hospital
Ansan-si, Gojan1-dong/Danwon-gu, South Korea
Korea University Guro Hospital
Seoul, Guro 2-Dong, Guro-Gu, South Korea
Samsung Medical Center
Seoul, Ilwon-dong/Gangnam-gu, South Korea
Seoul Asan Medical center
Seoul, Pungnab2-dong/Songpa-gu, South Korea
Recurrence Free Survival(RFS)
RFS was measured from the date of randomization to the first recurrence or to death from any cause.
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)
Recurrence Free Survival(RFS) Rate
RFS rate was measured from the date of randomization to the first recurrence or to death from any cause.
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)
Overall Survival(OS)
Overall survival was measured from the date of randomization until death from any cause.
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)
Cancer-specific Survivals
Cancer-specific survival was measured from the date of randomization until death resulting from HCC.
Time frame: 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)
Overall Survival(OS) Rate
Overall survival rate was measured from the date of randomization until death from any cause.
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)
Cancer-specific Survival Rate
Cancer-specific survival rate was measured from the date of randomization until death resulting from HCC.
Time frame: 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)
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Seoul National University Hospital
Seoul, Yeongun-dong/Jongro-gu, South Korea