Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-02-27 @ 5:10 PM
Study NCT ID:
NCT00493402
Status:
COMPLETED
Last Update Posted:
2012-12-17
First Post:
2007-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Different Regimens of Transarterial Chemoembolization for Hepatocellular Carcinoma
Sponsor:
Sun Yat-sen University
Organization:
Study Overview
Official Title:
The Efficacy, Safety, and Patient Reported Outcomes of Different Regimens of Transarterial Chemoembolization in Patients With Hepatocellular Carcinoma
Status:
COMPLETED
Status Verified Date:
2012-12
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:
TACEforHCC
Brief Summary:
The purpose of this study is to evaluate efficacy, safety, and patient reported outcomes (PRO) of different regimens of transarterial chemoembolization (TACE) in patients with hepatocellular carcinoma (HCC).
Detailed Description:
Transarterial chemoembolization (TACE) has been recommended as first line non-curative therapy for non-surgical patients with large/multifocal HCC who do not have vascular invasion or extrahepatic spread. There has not been any standardized protocol in the choice of chemotherapeutic agents, dosage, dilution, rate of injection, and time interval between treatments. Similarly, there is no agreement on the choice of embolizing agents, degree of embolization, and whether the chemotherapeutic agent should be given together, or before the embolizing agent.
Comparison(s): In patients with HCC who underwent TACE therapy, stratified by whether they have vascular invasion and tumor size, we compare efficacy, safety, and patient reported outcomes (PRO) of different regimens of TACE.
Regimen 1: lipiodol combined chemotherapy with embolization
Regimen 2: lipiodol combined chemotherapy without embolization
Regimen 3: lipiodol single agent chemotherapy with embolization
Comparison(s): In patients with HCC who underwent TACE therapy, stratified by whether they have vascular invasion and tumor size, we compare efficacy, safety, and patient reported outcomes (PRO) of different regimens of TACE.
Regimen 1: lipiodol combined chemotherapy with embolization
Regimen 2: lipiodol combined chemotherapy without embolization
Regimen 3: lipiodol single agent chemotherapy with embolization
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?: