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Chlorotrianisene

Patients will be randomized 1:1 to the control group and the treatment group. Patients who had allocated control group will not receive adjuvant treatment.

Patients will be randomized 1:1 to the control group and the treatment group. The treatment group will receive 6 times of MG4101(allogeneic natural killer cells) on week 0, 1, 2, 5, 6, 7.

MG4101 is ex vivo-expanded, allogeneic natural killer cells. MG4101 were manufactured from normal healthy donor who underwent lymphopheresis under good manufacturing practice (GMP) conditions.

MG4101

Jung Hwan Yoon, M.D., Ph.D.

The propose of this study is evaluate the safety and efficacy of MG4101 (allogeneic Natural killer cells) in patients with hepatocellular carcinoma (HCC) after transarterial chemoembolization (TACE).

This is randomized, multi-center, open-labeled, Phase 2a study in patients with HCC after transarterial chemoembolization (TACE). A total of 78 patients will be randomized(1:1) into one of the two group, to receive adjuvant therapy using MG4101 (allogeneic Natural killer cells, Treatment group) or no adjuvant therapy (Control group).

Patients who were assigned Treatment group will receive 2 cycles of MG4101 (each cycle is 3 treatments at a frequency of once per week, between each cycle has 3 weeks of withdrawal period). After treatment period, patients will undergo follow up for progression and survival every 12 weeks (± 7 days) and follow up 1 year after the last patient's enrollment date.

The Control group's patients will will undergo follow up for progression and survival every 12 weeks (± 7 days) and follow up 1 year after the last patient's enrollment date.

A Study of MG4101 (Allogeneic Natural Killer Cell) for Intermediate-stage of Hepatocellular Carcinoma

Multi-center, Open, Phase 2a Clinical Trial to Evaluate the Efficacy and Safety of MG4101 in Hepatocellular Carcinoma After TACE

GC Cell Corporation

Jae-Won Joh, MD., PhD

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.

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.

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

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

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.

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of MG4101 (Allogeneic Natural Killer Cell) for Intermediate-stage of Hepatocellular Carcinoma	NCT02854839	Hepatocellular ...	MG4101	18 Years - 80 Years	GC Cell Corporation
to Evaluate the Efficacy and Safety of MG4101(Ex Vivo Expanded Allogeneic NK Cell)	NCT02008929	Hepatocellular ...	MG4101	20 Years - 69 Years	Samsung Medical Center
to Evaluate the Efficacy and Safety of MG4101(Ex Vivo Expanded Allogeneic NK Cell)	NCT02008929	Hepatocellular ...	MG4101	20 Years - 69 Years	Samsung Medical Center
A Study of MG4101 (Allogeneic Natural Killer Cell) for Intermediate-stage of Hepatocellular Carcinoma	NCT02854839	Hepatocellular ...	MG4101	18 Years - 80 Years	GC Cell Corporation

Spots Global Cancer Trial Database for mg4101

Every month we try and update this database with for mg4101 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for mg4101

Every month we try and update this database with for mg4101 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for mg4101 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.