DAA in the Risk of Recurrence After Curative Treatment of HCC
Status:
Withdrawn
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
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
inclusion/exclusion 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.
Phase:
Phase 4
Details
Lead Sponsor:
Taipei Veterans General Hospital, Taiwan
Collaborators:
Chang Gung Memorial Hospital Chi Mei Medical Hospital Chia-Yi Christian Hospital Chiayi Christian Hospital China Medical University Hospital Kaohsiung Medical University Chung-Ho Memorial Hospital National Cheng-Kung University Hospital National Taiwan University Hospital Tri-Service General Hospital