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

NCT02008929 | Completed Phase 2 DMC

• 1 other identifier: HCC_ MG4101
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

NKCELL

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Changes in tumor markers

  Changes in tumor markers. to be specific, alpha-fetoprotein(AFP), protein induced by vitamin K absence- II(PIVKA-II)

• Overall survival, OS

  Overall survival, OS at the end point of clinical trial

Study Arms (1)

MG4101

OTHER

Ex vivo expanded allogeneic NK cell

Biological: MG4101

Interventions

MG4101 BIOLOGICAL

Ex vivo expanded allogeneic NK cell

Also known as: NK cell

MG4101

Eligibility Criteria

• Age: 20 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Jae-Won Joh, MD., PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 8, 2013
• First Posted: December 11, 2013
• Study Start: August 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 3, 2015

Record last verified: 2015-11

Locations

KR (1)