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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MG4101 | Other | Ex vivo expanded allogeneic NK cell |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MG4101 | Biological | Ex vivo expanded allogeneic NK cell |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jae-Won Joh, MD., PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 135-710 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34053923 | Derived | 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. |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| 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 |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |