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

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.

• MG4101 (Biological), also known as NK cell: Ex vivo expanded allogeneic NK cell

Primary outcomes

• Disease free survival, DFS [Disease free survival for 1year]: 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.

Secondary outcomes

• Changes in tumor markers [Changes in tumor markers. to be specific, alpha-fetoprotein(AFP), protein induced by vitamin K absence- II(PIVKA-II)]: 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.
• Overall survival, OS [Overall survival, OS at the end point of clinical trial]: 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.

Sex: All, ages: 20 Years to 69 Years

Inclusion Criteria:

1. Under the age of 20 to 69 years of age
2. Child-pugh class A
3. After curative liver resection, diagnosed hepatocellular carcinoma
4. Modified UICC staging : stage 3
5. the women who is childbearing age, agree to maintain adequate contraception measure during clinical trial period.
6. Agreed to participate in this clinical trial, agree to the subject person or legal representative who agrees in writing

Exclusion Criteria:

1. Less than 20 years old, 70 years old or older
2. Metastasis of hepatocellular carcinoma with external parties surgery
3. who had Rupture of hepatocellular carcinoma (HCC)
4. 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
5. suspected serious infection
6. Who have severe cardiovascular disease (coronary artery disease requiring treatment, heart failure, arrhythmias, myocardial infarction, etc.)
7. Pregnant, planning a pregnancy or breast-feeding women
8. Autoimmune Disease
9. 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)
10. Latest within four weeks of taking immunosuppressive drugs such as Cyclosporine A
11. Within the last 5 years diagnosed with liver cancer and other malignancies
12. 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

• Results publication: Kim JM, Cho SY, Rhu J, Jung M, Her JH, Lim O, Choi GS, Shin EC, Hwang YK, Joh JW. Adjuvant therapy using ex vivo-expanded allogenic natural killer cells in hepatectomy patients with hepatitis B virus related solitary hepatocellular carcinoma: MG4101 study. Ann Hepatobiliary Pancreat Surg. 2021 May 31;25(2):206-214. doi: 10.14701/ahbps.2021.25.2.206. PMID 34053923

• Jae-Won Joh, MD., PhD, Principal investigator, Samsung Medical Center