Ignite Creation Date:
2024-05-06 @ 1:46 AM
Last Modification Date:
2024-10-26 @ 11:09 AM
Study NCT ID:
NCT01897610
Status:
COMPLETED
Last Update Posted:
2023-06-26
First Post:
2013-06-25
Brief Title:
Efficacy and Safety of Immuncell-LC Group and Non-treatment Group in Nexavar Treated Patients for Advanced HCC
Sponsor:
GC Cell Corporation
Organization:
GC Cell Corporation
Study Overview
Official Title:
Randomized Open-label and Multi-center Clinical Trial to Evaluate the Efficacy and Safety of Immuncell-LC Group and Non-treatment Group in Nexavar Treated Patients for Advanced 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:
Immuncell-LC in aspects of therapeutic efficacy and safety when administered with Nexavar to advanced Hepatocellular carcinoma patients when compared with the control group who did not receive administration of the drug
Detailed Description:
primary outcome Compare clinical efficacy of group treated with cell therapeutic Immuncell-LC evaluated by progression free survival with that of untreated group
secondary outcome compare clinical efficacy of group treated with Immuncell-LC a drug for treating advanced hepatocellular carcinoma evaluated by overall survival disease control rate changes of Alpha Feto ProteinAFP figures from baseline to the last observation date and that of untreated group and evaluate adverse reactions clinical pathological tests and its safety
secondary outcome compare clinical efficacy of group treated with Immuncell-LC a drug for treating advanced hepatocellular carcinoma evaluated by overall survival disease control rate changes of Alpha Feto ProteinAFP figures from baseline to the last observation date and that of untreated group and evaluate adverse reactions clinical pathological tests and its safety
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None