to Evaluate the Efficacy and Safety of MG4101(Ex Vivo Expanded Allogeneic NK Cell)

Study Overview
=================
Brief Summary
-----------------
To see the safety and efficacy of injecting MG4101 as a secondary treatment after curative liver resection on the patient with advanced HCC who has high risk of recurrence.

Detailed Description
-----------------
To see the safety and efficacy of injecting MG4101(Ex vivo expanded allogeneic NK cell) as a secondary treatment after curative liver resection on the patient with advanced HCC who has high risk of recurrence.

Official Title
-----------------
A Single Center, Open-label, Phase II Clinical Trial to Evaluate the Efficacy and Safety of MG4101(Ex Vivo Expanded Allogeneic NK Cell) in Hepatocellular Carcinoma After Curative Resection

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Biological: MG4101


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Under the age of 20 to 69 years of age Child-pugh class A After curative liver resection, diagnosed hepatocellular carcinoma Modified UICC staging : stage 3 the women who is childbearing age, agree to maintain adequate contraception measure during clinical trial period. Agreed to participate in this clinical trial, agree to the subject person or legal representative who agrees in writing Exclusion Criteria: Less than 20 years old, 70 years old or older Metastasis of hepatocellular carcinoma with external parties surgery who had Rupture of hepatocellular carcinoma (HCC) Hepatocellular carcinoma treated with radiofrequency surgery therapeutics (Radiofrequency ablation, RFA), the carotid artery chemical embolization (Transarterial chemoembolization, TACE), underwent radiation therapy, such as topical therapeutics suspected serious infection Who have severe cardiovascular disease (coronary artery disease requiring treatment, heart failure, arrhythmias, myocardial infarction, etc.) Pregnant, planning a pregnancy or breast-feeding women Autoimmune Disease Those who Latest within four weeks of administration of systemic steroids (However, inhalation, intranasal corticosteroids and topical administration of corticosteroids and short-time administration of a blood transfusion, if such reasons are excluded) Latest within four weeks of taking immunosuppressive drugs such as Cyclosporine A Within the last 5 years diagnosed with liver cancer and other malignancies Investigator did not complete or the effectiveness or safety of pharmaceutical products of this clinical trial evaluation for any medical condition that can interfere with characters judged

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 69 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: MG4101<br>Ex vivo expanded allogeneic NK cell | Biological: MG4101<br>* Ex vivo expanded allogeneic NK cell<br>* Other names: NK cell;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival, DFS | As of Date for allocation to survival and recurrence of the incident or death from any cause is defined as. 1 year disease-free survival was calculated using Kaplan-Meier estimation and 95% confidence interval and median survival (median survival time) are presented. | Disease free survival for 1year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in tumor markers | Basaline(V2) at each visit compared (V6, V8, V9, V10) with respect to variation in average by descriptive statistics (mean, standard deviation, median, minimum, maximum) and presented, in comparison to the group in order Paired t-test or the Wilcoxon's signed rank test for analysis. | Changes in tumor markers. to be specific, alpha-fetoprotein(AFP), protein induced by vitamin K absence- II(PIVKA-II) | 
| Overall survival, OS | As of Date for allocation to survival, and the incident was defined as death from any cause. 1 year overall survival was calculated using Kaplan-Meier estimation and 95% confidence interval and median survival (median survival time) are presented. | Overall survival, OS at the end point of clinical trial | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NKCELL