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Completed

NCT Number: NCT02008929

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

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.

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Key information

Conditions

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

Age range

20 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MG4101

Biological

Ex vivo expanded allogeneic NK cell

Other names: NK cell

Primary outcomes

  1. Disease free survival, DFS

    Time frame: Disease free survival for 1year

    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 outcomes

  1. Changes in tumor markers

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

    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.

  2. Overall survival, OS

    Time frame: Overall survival, OS at the end point of clinical trial

    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.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study 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

Acronym: MG4101

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 11, 2013
Registry last updated
Dec 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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