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

Hepatocellular Carcinoma Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02008929
• Other study ID #: HCC_ MG4101
• Status: Completed
• Phase: Phase 2
• First received: December 8, 2013
• Last updated: November 30, 2015
• Start date: August 2014
• Est. completion date: October 2015

Study information

• Verified date: November 2015
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 69 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Biological:
• MG4101
Ex vivo expanded allogeneic NK cell

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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.	Changes in tumor markers. to be specific, alpha-fetoprotein(AFP), protein induced by vitamin K absence- II(PIVKA-II)	No
Secondary	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.	Overall survival, OS at the end point of clinical trial	No