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

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
MG4101
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring NKCELL

Eligibility Criteria

20 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

MG4101

Arm Description

Ex vivo expanded allogeneic NK cell

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
December 8, 2013
Last Updated
November 30, 2015
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02008929
Brief Title
to Evaluate the Efficacy and Safety of MG4101(Ex Vivo Expanded Allogeneic NK Cell)
Acronym
MG4101
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
NKCELL

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MG4101
Arm Type
Other
Arm Description
Ex vivo expanded allogeneic NK cell
Intervention Type
Biological
Intervention Name(s)
MG4101
Other Intervention Name(s)
NK cell
Intervention Description
Ex vivo expanded allogeneic NK cell
Primary Outcome Measure Information:
Title
Disease free survival, DFS
Description
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.
Time Frame
Disease free survival for 1year
Secondary Outcome Measure Information:
Title
Changes in tumor markers
Description
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.
Time Frame
Changes in tumor markers. to be specific, alpha-fetoprotein(AFP), protein induced by vitamin K absence- II(PIVKA-II)
Title
Overall survival, OS
Description
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.
Time Frame
Overall survival, OS at the end point of clinical trial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae-Won Joh, MD., PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
34053923
Citation
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.
Results Reference
derived

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