Ignite Creation Date:
2024-05-06 @ 1:32 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01833299
Status:
COMPLETED
Last Update Posted:
2020-02-11
First Post:
2011-04-13
Brief Title:
Transcatheter Arterial Chemoembolization Combined With Sorafenib for Unresectable Hepatocellular Carcinoma
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
Transcatheter Arterial Chemoembolization Combined With Sorafenib for Unresectable Hepatocellular Carcinoma
Status:
COMPLETED
Status Verified Date:
2020-02
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:
Hepatocellular carcinoma HCC is the 6th most common cancer and the third most frequent cause of cancer death worldwide Hepatic resection HR has been the standard treatment modality for HCC aiming at clinical cure In both Europe and Unit States proposed guidelines for HCC HR was recommend only for patients with a single HCC lesion and preserved liver function Unfortunately only 10-30 of HCCs are amenable to such curative surgical resection at the time of diagnosis because of tumor multifocality portal vein invasion and underlying advanced liver cirrhosis Alternatively transarterial chemoembolization TACE has become the most popular modality for palliative treatment for the other patients However the long term outcomes were generally poor for HCC patients treated with TACE
Recently sorafenib has shown some promises in improvement of 3-month survival among patients with advanced HCC It is claimed that sorafenib has become the standard of care for patients advanced HCC
Thus the purpose of this study was to prospectively compare the effectiveness of sorafenib combined with TACE with that of TACE alone in the treatment of unresectable HCC
Recently sorafenib has shown some promises in improvement of 3-month survival among patients with advanced HCC It is claimed that sorafenib has become the standard of care for patients advanced HCC
Thus the purpose of this study was to prospectively compare the effectiveness of sorafenib combined with TACE with that of TACE alone in the treatment of unresectable HCC
Detailed Description:
Hepatocellular carcinoma HCC is a common cause of cancer mortality in Asia Most patients present with intermediate or advanced disease Percutaneous ethanol injection radiofrequency ablation and transcatheter arterial chemoembolization TACE are not considered as a curative treatment and have achieved very limited success in eradicating large HCC
Two phase III trials were shown to be efficacious and well-tolerated in patients with advanced HCC Median overall survival was significantly 2 to 3 months longer in the sorafenib group than that in the placebo It is interesting to recognize the combined therapeutic effect of TACE with sorafenib The proposed study will make an important contribution to understanding not only the safety and efficacy of sorafenib in addition to TACE in patients diagnosed with unresectable HCC but this will also be the first clinical trial prospectively to compare the effectiveness of sorafenib combined with TACE with that of TACE alone in the treatment of unresectable HCC
Two phase III trials were shown to be efficacious and well-tolerated in patients with advanced HCC Median overall survival was significantly 2 to 3 months longer in the sorafenib group than that in the placebo It is interesting to recognize the combined therapeutic effect of TACE with sorafenib The proposed study will make an important contribution to understanding not only the safety and efficacy of sorafenib in addition to TACE in patients diagnosed with unresectable HCC but this will also be the first clinical trial prospectively to compare the effectiveness of sorafenib combined with TACE with that of TACE alone in the treatment of unresectable HCC
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