A Phase 1/2 interventional study of Immuncell-LC in Liver Transplantation, sponsored by GC Cell Corporation. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-06-22.
Sponsored by GC Cell Corporation · Phase 1/2, Interventional, and Treatment
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.
GC Cell Corporation is the lead sponsor of 15 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Absolute neutrophil count > 500x10\^6L Hemoglobin ≥ 7.5 g/dL Platelet count > 20,000/㎣ Total bilirubin \< 15mg/㎗
•Patients who have agreed to participate in the study voluntarily by signing on informed consent form.
Exclusion Criteria:
Adjuvant adoptive immune therapy using a CIK cell agent(Cytokine-Induced Killer cells; Immuncell-LC) 3 times(3 treatments at a frequency of once per week) or 6 times(3 treatments at a frequency of once per week followed by 3 treatments every 2 weeks)
Biological: Immuncell-LC
Activated T lymphocyte
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
Plan to share: No
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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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GC Cell Corporation