Ignite Creation Date:
2024-05-06 @ 9:19 AM
Last Modification Date:
2024-10-26 @ 12:13 PM
Study NCT ID:
NCT02959359
Status:
WITHDRAWN
Last Update Posted:
2017-08-07
First Post:
2016-10-30
Brief Title:
DAA in the Risk of Recurrence After Curative Treatment of HCC
Sponsor:
Taipei Veterans General Hospital Taiwan
Organization:
Taipei Veterans General Hospital Taiwan
Study Overview
Official Title:
The Role of DAA in Reducing the Risk of Recurrence After Curative Treatment of HCC in Patients With Chronic Hepatitis C and Early Stage HCC
Status:
WITHDRAWN
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The supplies of study drug were halted by Gilead Sciences Ltd
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
For early stage of HCC surgical resection or radiofrequency ablation RFA is the mainstay curative treatments However recurrence is still a major issue after the surgery or RFA Only selected patients are eligible and tolerable to IFN-based treatment after surgical resection and the sustained virological response varied
Harvoni for genotype 1 HCV and sovaldi plus ribavirin for genotype 2 HCV can achieve high SVR and being recommended by AASLD and EASL Mixed HCV genotype infection accounts for 10 of CHC patients in Taiwan Sovaldi-based treatment plus ribavirin should be as effective as Sovaldi plus rivavirin in the treatment of genotype 2 HCV as well as mixed genotype 1 and 2 HCV infection As genotype 1 and 2 are the leading HCV genotypes in Taiwan It can simplify the regimen of anti-HCV treatment in Taiwan by using Harvoni plus ribavirin not only for genotype 1 and 2 HCV but also for mixed genotype 1 and 2 HCV infection Although an unexpected high recurrence rate in HCC patients under DAA treatment was reported once However one recent study showed a low risk of HCC recurrence after DAA treatment In this study the investigators plan to enroll 130 HCV-HCC patients after confirming curative treatment for their HCC either by surgery or RFA For the cases fulfilling the inclusionexclusion criteria a 12 weeks Harvoni plus ribavirin treatment will be provided for all cases single armed design The primary objective of the study is annual recurrence-free survival after curative resection of HCV-HCC for up to 5 years A hospital-based cohorts of HCV-related HCC undergoing surgical resection or RFA from Taipei Veterans General Hospital and Investigated Sites will be recruited as historical controls
Harvoni for genotype 1 HCV and sovaldi plus ribavirin for genotype 2 HCV can achieve high SVR and being recommended by AASLD and EASL Mixed HCV genotype infection accounts for 10 of CHC patients in Taiwan Sovaldi-based treatment plus ribavirin should be as effective as Sovaldi plus rivavirin in the treatment of genotype 2 HCV as well as mixed genotype 1 and 2 HCV infection As genotype 1 and 2 are the leading HCV genotypes in Taiwan It can simplify the regimen of anti-HCV treatment in Taiwan by using Harvoni plus ribavirin not only for genotype 1 and 2 HCV but also for mixed genotype 1 and 2 HCV infection Although an unexpected high recurrence rate in HCC patients under DAA treatment was reported once However one recent study showed a low risk of HCC recurrence after DAA treatment In this study the investigators plan to enroll 130 HCV-HCC patients after confirming curative treatment for their HCC either by surgery or RFA For the cases fulfilling the inclusionexclusion criteria a 12 weeks Harvoni plus ribavirin treatment will be provided for all cases single armed design The primary objective of the study is annual recurrence-free survival after curative resection of HCV-HCC for up to 5 years A hospital-based cohorts of HCV-related HCC undergoing surgical resection or RFA from Taipei Veterans General Hospital and Investigated Sites will be recruited as historical controls
Detailed Description:
Chronic hepatitis C virus HCV infection is a major etiology of hepatocellular carcinoma HCC For early stage of HCC surgical resection or radiofrequency ablation RFA is the mainstay curative treatments However recurrence is still a major issue after the surgery or RFA According to our previous report the cumulated recurrence rate for small HCV-HCC was 724 at 5 year PEG-interferon plus RBV treatment is the standard of care for chronic hepatitis C CHC in Taiwan NHIRD data showed that PEG-IFN plus RBV treatment can reduce 12 of recurrence rate in 5 years 64 vs 52 after curative resection of HCC However only selected patients are eligible and tolerable to IFN-based treatment after surgical resection and the sustained virological response varied
Harvoni for genotype 1 HCV and sovaldi plus ribavirin for genotype 2 HCV can achieve high SVR and being recommended by AASLD and EASL All-oral regimen being more tolerable and effective for HCC patients after curative treatment than IFN-based treatment Mixed HCV genotype infection accounts for 10 of CHC patients in Taiwan Sovaldi-based treatment plus ribavirin should be as effective as Sovaldi plus rivavirin in the treatment of genotype 2 HCV as well as mixed genotype 1 and 2 HCV infection As genotype 1 and 2 are the leading HCV genotypes in Taiwan It can simplify the regimen of anti-HCV treatment in Taiwan by using Harvoni plus ribavirin not only for genotype 1 and 2 HCV but also for mixed genotype 1 and 2 HCV infection Although an unexpected high recurrence rate in HCC patients under DAA treatment was reported once However one recent study showed a low risk of HCC recurrence after DAA treatment Harvoni is an all-oral regimen being more tolerable and effective for HCC patients after surgery than IFN-based treatment The all oral regimen would be beneficial in eradicating HCV viral load and subsequently reduce the risk of recurrence after curative resection of HCV-HCC
In this study the investigators plan to enroll 130 HCV-HCC patients after confirming curative treatment for their HCC either by surgery or RFA For the cases fulfilling the inclusionexclusion criteria a 12 weeks Harvoni plus ribavirin treatment will be provided for all cases single armed design The primary objective of the study is annual recurrence-free survival after curative resection of HCV-HCC for up to 5 years The secondary objectives of the study are SVR 41224 by DAA regression of fibrosis incidence of liver-related complications EV bleeding ascites after DAA treatment and overall survival for 5 years
A hospital-based cohorts of HCV-related HCC undergoing surgical resection or RFA from Taipei Veterans General Hospital and Investigated Sites will be recruited as historical controls The historical controls include HCV-HCC undergoing curative treatment without Peg-interferon plus ribavirin treatment cohort 1 or with Peg-interferon plus ribavirin treatment cohort 2 after curative treatment surgical resection or RFA for HCC
Harvoni for genotype 1 HCV and sovaldi plus ribavirin for genotype 2 HCV can achieve high SVR and being recommended by AASLD and EASL All-oral regimen being more tolerable and effective for HCC patients after curative treatment than IFN-based treatment Mixed HCV genotype infection accounts for 10 of CHC patients in Taiwan Sovaldi-based treatment plus ribavirin should be as effective as Sovaldi plus rivavirin in the treatment of genotype 2 HCV as well as mixed genotype 1 and 2 HCV infection As genotype 1 and 2 are the leading HCV genotypes in Taiwan It can simplify the regimen of anti-HCV treatment in Taiwan by using Harvoni plus ribavirin not only for genotype 1 and 2 HCV but also for mixed genotype 1 and 2 HCV infection Although an unexpected high recurrence rate in HCC patients under DAA treatment was reported once However one recent study showed a low risk of HCC recurrence after DAA treatment Harvoni is an all-oral regimen being more tolerable and effective for HCC patients after surgery than IFN-based treatment The all oral regimen would be beneficial in eradicating HCV viral load and subsequently reduce the risk of recurrence after curative resection of HCV-HCC
In this study the investigators plan to enroll 130 HCV-HCC patients after confirming curative treatment for their HCC either by surgery or RFA For the cases fulfilling the inclusionexclusion criteria a 12 weeks Harvoni plus ribavirin treatment will be provided for all cases single armed design The primary objective of the study is annual recurrence-free survival after curative resection of HCV-HCC for up to 5 years The secondary objectives of the study are SVR 41224 by DAA regression of fibrosis incidence of liver-related complications EV bleeding ascites after DAA treatment and overall survival for 5 years
A hospital-based cohorts of HCV-related HCC undergoing surgical resection or RFA from Taipei Veterans General Hospital and Investigated Sites will be recruited as historical controls The historical controls include HCV-HCC undergoing curative treatment without Peg-interferon plus ribavirin treatment cohort 1 or with Peg-interferon plus ribavirin treatment cohort 2 after curative treatment surgical resection or RFA for 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