Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT03983967
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
2019-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluate the Efficacy and Safety of 'Immuncell-LC' in Patients Undergoing Liver Transplantation
Sponsor:
GC Cell Corporation
Organization:
Study Overview
Official Title:
Increased Dose, Repeated Injection Clinical to Evaluate the Efficacy and Safety of 'Immuncell-LC' in Patients Undergoing Liver Transplantation With Hepatocellular Carcinoma Exceeding the Milan Criteria
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to investigate and validate the maximum tolerated dose (MTD) or maximum available dose (MFD), safety and efficacy on patients with hepatocellular carcinoma beyond Milan criteria who undergo liver transplantation.
Detailed Description:
ILC-IIT-07 is open-label, phase 1/2 clinical trial to confirm safety on patients with hepatocellular carcinoma beyond Milan criteria who undergo liver transplantation. For primary outcome, maximum feasible dose (MFD) or maximum tolerated dose (MTD) will be evaluated.
For secondary outcome, Time to Recurrence(TTR), Recurrence-Free Survival(RFS), Overall Survival(OS) will be evaluated.
For secondary outcome, Time to Recurrence(TTR), Recurrence-Free Survival(RFS), Overall Survival(OS) will be evaluated.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: