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

NCT ID: NCT02008929

Last Updated: 2015-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-10-31

Brief Summary

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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

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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.

Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MG4101

Ex vivo expanded allogeneic NK cell

Group Type OTHER

MG4101

Intervention Type BIOLOGICAL

Ex vivo expanded allogeneic NK cell

Interventions

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MG4101

Ex vivo expanded allogeneic NK cell

Intervention Type BIOLOGICAL

Other Intervention Names

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NK cell

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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JAE WON JOH

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jae-Won Joh, MD., PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 34053923 (View on PubMed)

Other Identifiers

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HCC_ MG4101

Identifier Type: -

Identifier Source: org_study_id