Ignite Creation Date:
2024-05-06 @ 8:55 AM
Last Modification Date:
2024-10-26 @ 12:07 PM
Study NCT ID:
NCT02856815
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
2016-07-28
Brief Title:
Safety and Efficacy of Immuncell-LC in TACE Therapy
Sponsor:
GC Cell Corporation
Organization:
GC Cell Corporation
Study Overview
Official Title:
Randomized Open-label Multi-center and Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of Immuncell-LC Group and Non-treatment Group in the Patients Undergone TACE for Intermediate Stage Hepatocellular Carcinoma
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:
To evaluate the efficacy and safety of Immuncell-LC group and non-treatment group in the patients undergone Transarterial Chemoembolization for intermediate stage hepatocellular carcinoma
Detailed Description:
ILC-IIT-05 is randomized open-label multi-center phase 2 clinical trial To confirm clinical efficacy and safety between Immuncell-LC group and non-treatment group primary outcome recurrence free survivalRFS will be evaluated
For secondary outcome overall survivalOS changes of Alpha Feto ProteinAFP correlation of between myeloid-derived suppressor cell change and prognosis adverse event ECOG-PS and hematological examination will be evaluated
For secondary outcome overall survivalOS changes of Alpha Feto ProteinAFP correlation of between myeloid-derived suppressor cell change and prognosis adverse event ECOG-PS and hematological examination will be evaluated
Study Oversight
Has Oversight DMC:
None
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?:
None