The purpose of this study is to investigate and validate the maximum tolerated dose (MTD) or maximum available dose (MFD), safety and efficacy on patients with hepatocellular carcinoma beyond Milan criteria who undergo liver transplantation.
ILC-IIT-07 is open-label, phase 1/2 clinical trial to confirm safety on patients with hepatocellular carcinoma beyond Milan criteria who undergo liver transplantation. For primary outcome, maximum feasible dose (MFD) or maximum tolerated dose (MTD) will be evaluated. For secondary outcome, Time to Recurrence(TTR), Recurrence-Free Survival(RFS), Overall Survival(OS) will be evaluated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Activated T lymphocyte
Seoul National Hospital
Seoul, South Korea
maximum tolerated dose (MTD) or maximum feasible dose (MFD)
The observation of maximum tolerated dose (MTD) or maximum feasible dose (MFD) evaluation(1X10\^7cell, 5X10\^7cell, 10X10\^7cells) of immuncell-LC on hepatocellular carcinoma patients who undergo liver transplantation
Time frame: Every visit from the baseline until 44 weeks, and then every 3 months until the data cut-off date or 12 months from baseline of last subject
Time to Recurrence
Time to Recurrence is defined as the recurring time of the cancer.
Time frame: Every visit from the baseline until 44 weeks, and then every 3 months until the data cut-off date or 12 months from baseline of last subject
Recurrence-Free Survival
Recurrence-Free Survival is defined as the recurring time of the cancer or death.
Time frame: Every visit from the baseline until 44 weeks, and then every 3 months until the data cut-off date or 12 months from baseline of last subject
Overall Survival
Overall Survival is defined as the time of death from administraion of investigational product.
Time frame: Every visit from the baseline until 44 weeks, and then every 3 months until the data cut-off date or 12 months from baseline of last subject
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