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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immuncell-LC group | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immuncell-LC | Biological | Activated T lymphocyte |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Recurrence | Time to Recurrence is defined as the recurring time of the cancer. | 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 |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Kyung Suk Suh, MD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National Hospital | Seoul | 110-744 | South Korea |
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Liver cancer patients undergoing liver transplantation with hepatocellular carcinoma exceeding the Milan criteria
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Recurrence-Free Survival is defined as the recurring time of the cancer or death. |
| 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. | 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 |