Safety and Efficacy of Immuncell-LC in TACE Therapy

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of 'Immuncell-LC group' and 'non-treatment group' in the patients undergone Transarterial Chemoembolization for intermediate stage hepatocellular carcinoma

Detailed Description
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ILC-IIT-05 is randomized, open-label, multi-center phase 2 clinical trial. To confirm clinical efficacy and safety between 'Immuncell-LC group' and 'non-treatment group', primary outcome, recurrence free survival(RFS) will be evaluated. For secondary outcome, overall survival(OS), changes of Alpha Feto Protein(AFP), correlation of between myeloid-derived suppressor cell change and prognosis, adverse event, ECOG-PS and hematological examination will be evaluated.

Official Title
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Randomized, Open-label, Multi-center and Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of 'Immuncell-LC Group' and 'Non-treatment Group' in the Patients Undergone TACE for Intermediate Stage Hepatocellular Carcinoma

Conditions
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Carcinoma, Hepatocellular

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 have consented to the study by providing signature of self Patients who are more than 20 and less than 80 years old Child-Pugh Class should be A(score 5-6) or B(score 7-8) ECOG Performance Status (ECOG-PS) score is less than 1 or equal to Patients who have been diagnosed with BCLC stage B hepatocellular carcinoma by pathological/radiological test(Dynamic contrast-enhanced CT or Dynamic MRI) and tumor removal has been confirmed after TACE (When patients have been diagnosed with recurrence of hepatocellular carcinoma after surgery or local treatment, if conditions are same as above, patients could be included) Patients who satisfy the following conditions of the blood test and kidney, liver function test Absolute neutrophil count > 500/µL Hemoglobin ≥ 8.5 g/dL Platelet count > 50,000/µL Blood Creatinine ≤ 1.5xupper normal limit Total bilirubin < 3mg/dL Albumin ≥ 2.8g/dL Exclusion Criteria: Patients who have been confirmed with residual tumor or extrahepatic metastases Patients who have lymph node metastases or portal vein, hepatic vein invasion Patients who have a history of treatments or are in conditions as below Liver transplantation From Informed consent form sign date, systemic chemotherapy in 4 weeks or ongoing adverse drug reactions from anticancer drug in 6 weeks External beam radiation, immunotherapy, molecular target therapy More than 2 times of systemic chemotherapy Biliary reconstruction or endoscopic biliary treatment Patients who have a history of auto-immune diseases (Ex. Rheumatoid Arthritis, Systemic Lupus Erythematosus, Vasculitis, Multiple sclerosis, Adolescent Insulin-Dependent Diabetes Mellitus, etc.) Patients who have a history of malignant tumors in the recent 5 years prior to the study except hepatocellular carcinoma Patients who participated in another clinical trial and conducted 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 Pregnant women or nursing mother Patients who intend to get pregnant during the study

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
Allocation: Randomized
Intervention Model: Parallel Assignment
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(Immuncell-LC) 12 times(5 treatments at a frequency of once per week, followed by 5 treatments every 2 weeks, and finally 2 treatments every 4 weeks. | Biological: Immuncell-LC<br>* Activated T lymphocyte : intravenous dripping of 200ml (1 x 10^9   2 x 10^10 lymphocytes / 60kg adult) for 1 hour<br>|
| No Intervention: Non-treatment group<br>Non-treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence Free Survival (RFS) | Every 12 weeks 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 | 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 |
| --- | --- | --- |
| Overall Survival (OS) | Every 12 weeks 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 | baseline until 44 weeks, and then every 3 months until the data cut-off date or 12 months from baseline of last subject | 
| Change of Alpha Feto Protein (AFP) level | Every 12 weeks 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 | Every 12 weeks 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 | 
| Correlation of between Myeloid-derived Suppressor Cell change and Prognosis | Every 12 weeks from the baseline until 4 weeks after the last dose of immunotherapy | Every 12 weeks from the baseline until 4 weeks after the last dose of immunotherapy | 
| Adverse event | From the time the patient provided written informed consent until drop-out or the end of the study or at least 4 weeks after the last dose of immunotherapy | From the time the patient provided written informed consent until drop-out or the end of the study or at least 4 weeks after the last dose of immunotherapy | 
| Eastern Cooperative Oncology Group Performance Status (ECOG-PS) | From the time the patient provided written informed consent until drop-out or the end of the study or 4 weeks after the last dose of immunotherapy | From the time the patient provided written informed consent until drop-out or the end of the study or 4 weeks after the last dose of immunotherapy | 
| Hematological examination | Every 12 weeks from the baseline until 4 weeks after the last dose of immunotherapy | Every 12 weeks from the baseline until 4 weeks after the last dose of immunotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immuncell-LC, Transarterial Chemoembolization