DAA in the Risk of Recurrence After Curative Treatment of HCC

• Status: Withdrawn
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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
• Treatments: Ledipasvir; Ribavirin; Sofosbuvir

Criteria

Inclusion Criteria:

• Anti-HCV positive and HBsAg-negative

• HCV genotype 1 or 2 infection, mixed infection GT 1 & 2 is allowed

• HCV RNA ≥ 10,000 IU/ml at the time of screening

• Age > 20 y/o

• BCLC stage 0 or A HCC confirmed by pathology and receiving the first time of curative treatment

• No recurrence of HCC confirmed by contrast-enhanced image studies (CT or MRI) within 3 months post the curative treatment.

• Performance status Eastern Cooperative Oncology Group (ECOG) 0-1

• Child-Pugh score ≤7

Exclusion Criteria:

• HBV, or HIV coinfection

• Co-existing other malignancy

• Intolerance to ribavirin

• Marked decompensated liver cirrhosis (CTP score>7)

• Uremia or renal impaired patients (eGFR<30)