MG4101
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
Sponsor study identifier
interventional
5
1 country
1
Study Start
August 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2015
Actual (reported)Study Completion
October 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 8, 2013
Actual (reported)December 11, 2013
Actual (reported)August 2014
Date type not reportedThis date has not been verified as actual or estimated.
October 2015
Actual (reported)October 2015
Actual (reported)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
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
Ex vivo expanded allogeneic NK cell
Ex vivo expanded allogeneic NK cell
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Samsung Medical Center
Seoul, 135-710, South Korea
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.
Jae-Won Joh, MD., PhD
Samsung Medical Center
5 participants (actual enrollment reported by the registry).
First Submitted
December 8, 2013
First Posted
December 11, 2013
Study Start
August 2014
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
October 2015
Actual (reported)Study Completion
October 2015
Actual (reported)Last Updated
December 3, 2015
Record last verified: 2015-11
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Source: ClinicalTrials.gov.
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