Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-25 @ 7:24 PM
Study NCT ID:
NCT01715532
Status:
UNKNOWN
Last Update Posted:
2015-12-18
First Post:
2012-08-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Role of Huachansu in Treating Hepatocellular Carcinoma and the Correlation With Na+/K+-ATPase
Sponsor:
Fudan University
Organization:
Study Overview
Official Title:
Phase II Study of Huachansu for Treatment of Advanced Hepatocellular Carcinoma and the Correlation With Na+/K+-ATPase
Status:
UNKNOWN
Status Verified Date:
2015-12
Last Known Status:
RECRUITING
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:
Primary Outcome Measures:
\- To compare the progression free survival(PFS) in patients with unresectable hepatocellular carcinoma(HCC) treated with transcatheter arterial chemoembolization(TACE) with or without Huachansu, and the correlation between PFS and expression of peripheral Na+/K+-ATPase α3 family.
Secondary Outcome Measures:
\- To compare the overall survival(OS), objective response rate(ORR), and side effects of treating HCC with TACE plus Huachansu or TACE alone.
Exploratory Outcome Measures:
\- To evaluate the correlation between prognosis and expression of peripheral Na+/K+-ATPase α3 family.
\- To compare the progression free survival(PFS) in patients with unresectable hepatocellular carcinoma(HCC) treated with transcatheter arterial chemoembolization(TACE) with or without Huachansu, and the correlation between PFS and expression of peripheral Na+/K+-ATPase α3 family.
Secondary Outcome Measures:
\- To compare the overall survival(OS), objective response rate(ORR), and side effects of treating HCC with TACE plus Huachansu or TACE alone.
Exploratory Outcome Measures:
\- To evaluate the correlation between prognosis and expression of peripheral Na+/K+-ATPase α3 family.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: