Ignite Creation Date:
2024-05-06 @ 7:17 AM
Last Modification Date:
2024-10-26 @ 11:46 AM
Study NCT ID:
NCT02504983
Status:
UNKNOWN
Last Update Posted:
2020-02-05
First Post:
2015-07-16
Brief Title:
Clinical Trial for GALNT14 Genotype - Guided Sorafenib in Combination With TACE in Hepatocellular Carcinoma
Sponsor:
Chang Gung Memorial Hospital
Organization:
Chang Gung Memorial Hospital
Study Overview
Official Title:
Randomized Open Label Clinical Trial for GALNT14 Genotype - Guided Sorafenib in Combination With TACE Therapy in Hepatocellular Carcinoma
Status:
UNKNOWN
Status Verified Date:
2020-02
Last Known Status:
ACTIVE_NOT_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:
Transcatheter arterial chemoembolization TACE sorafenib therapy has been demonstrated to exert a beneficial effective on time-to-tumor-progression TTP in patients with unresectable hepatocellular carcinoma HCC in some studies However the beneficial effect varies among studies conducted in different areas of the world The objectives of this study are 1 to understand whether GALNT14 TT genotype patients respond better than do GALNT14 non-TT genotype patients when treated by TACE and 2 to understand whether GALNT14 non-TT genotype patients can benefit from TACE plus sorafenib Nexavar combination therapy Patients enrolled will be stratified by GALNT14 genotyping The GALNT14 non-TT patients were then randomized into two subgroups to evaluate the safety tolerability and efficacy of TACE plus sorafenib therapy
The primary endpoint of this study is the efficacy of TACE with or without sorafenib combination therapy evaluated by complete remission CR
The secondary endpoints are
1 Time to partial or complete response PR CR
2 Time-to-tumor-progression TTP and the progression free survival PFS
3 Overall survival OS
4 Safety and tolerability of TACE plus sorafenib therapy
The primary endpoint of this study is the efficacy of TACE with or without sorafenib combination therapy evaluated by complete remission CR
The secondary endpoints are
1 Time to partial or complete response PR CR
2 Time-to-tumor-progression TTP and the progression free survival PFS
3 Overall survival OS
4 Safety and tolerability of TACE plus sorafenib therapy
Detailed Description:
The strategy of TACE sorafenib is now being intensively investigated It is a safe approach with significant beneficial effect on TTP in some studies but the beneficial effect on OS remains uncertain In the present study we hypothesized that the GALNT14 genotype might play a role in this issue Our pilot study indicated that GALNT14 TT genotype was associated with a favorable complete response rate in patients treated by TACE alone This genotype was present in 25 of Chinese population coming from Taiwan Colorado US or Beijing China and in 7 of Italian population But it was present in 50 of Japanese population The lower percentage of a TACE - favorable genotype in Chinese and Italian population could explain the different results between Japanese and ChineseItalian clinical trials It is possible that in a population with higher percentage of TACE - favorable genotype GALNT14 TT the beneficial effect of sorafenib adjuvant treatment might not be detected In this study we proposed to examine the TACE sorafenib effect in patients with GALNT14 non-TT genotype a TACE - unfavorable genotype
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