Evaluate the Efficacy and Safety of 'Immuncell-LC' in Patients Undergoing Liver Transplantation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Increased Dose, Repeated Injection Clinical to Evaluate the Efficacy and Safety of 'Immuncell-LC' in Patients Undergoing Liver Transplantation With Hepatocellular Carcinoma Exceeding the Milan Criteria

Conditions
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Liver Transplantation

Intervention / Treatment
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* Biological: Immuncell-LC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are more than 20 and less than 80 years old. Patients whose expected life expectancy is at least 16 weeks (4 months). Patients who receive liver transplants exceeding the Milan Criteria. ECOG Performance Status (ECOG-PS) score is 0-2. Patients who satisfy the following conditions of the blood test and kidney, liver function test. 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: Patients who have received in vitro radiation therapy, systemic chemotherapy within 4 weeks based on sign date of Informed consent form. Patients who undergo ABO incompatible Liver Transplantation. Patients who had previously administered cell therapy. Patients who are confirmed with Acquired Immune Deficiency Syndrome (AIDS). Patients who are currently receiving dialysis. Patients who participated in another clinical trial and received treatment in 4 weeks or have a plan for administration of another clinical trial treatment since Informed consent form sign date. Patients who have uncontrollable or serious disease. Patients who are unable to use appropriate methods of contraception during the study period. Patient whose tumor has not been removed or liver metastasis is confirmed.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Liver cancer patients undergoing liver transplantation with hepatocellular carcinoma exceeding the Milan criteria
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immuncell-LC group<br>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<br>* Activated T lymphocyte<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |