DAA in the Risk of Recurrence After Curative Treatment of HCC

NCT02959359 | Withdrawn Phase 4

• 1 other identifier: GILEAD IN-US-337-4109
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Hepatocellular Carcinoma

Keywords

Chronic hepatitis C; Hepatocellular Carcinoma; Direct-acting antiviral (DAA); Recurrence

Outcome Measures

Primary Outcomes (1)

• The primary objective of the study is annual recurrence-free survival after curative resection of HCV-HCC for up to 5 years.

  The primary objective of the study is annual recurrence-free survival after curative resection of HCV-HCC for up to 5 years.

  up to 5 years

Secondary Outcomes (4)

• SVR 4/12/24 by DAA

  up to 5 years

• Regression of fibrosis

  up to 5 years

• Incidence of liver-related complications (EV bleeding, ascites) after DAA treatment

  up to 5 years

• Overall survival

  up to 5 years

Study Arms (1)

DAA treatment arm

OTHER

Active DAA treatment ('Ledipasvir 90mg/Sofosbuvir 400 mg plus Ribavirin' ) for HCV-HCC patients after curative resection or ablation.

Drug: Ledipasvir 90mg/Sofosbuvir 400 mg; Drug: Ribavirin

Interventions

Ledipasvir 90mg/Sofosbuvir 400 mg DRUG

A 12 week Harvoni (Ledipasvir 90mg/Sofosbuvir 400 mg ) plus ribavirin will be provided after confirmation of curative treatment.

Also known as: DAA

DAA treatment arm

Ribavirin DRUG

A 12 week Harvoni (Ledipasvir 90mg/Sofosbuvir 400 mg ) plus ribavirin will be provided after confirmation of curative treatment.

Also known as: rebetol

DAA treatment arm

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead
• Kaohsiung Medical University Chung-Ho Memorial Hospital: collaborator
• China Medical University Hospital: collaborator
• Chi Mei Medical Hospital: collaborator
• Chiayi Christian Hospital: collaborator
• National Taiwan University Hospital: collaborator
• Chang Gung Memorial Hospital: collaborator
• Tri-Service General Hospital: collaborator
• National Cheng-Kung University Hospital: collaborator

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Hepatitis C, Chronic; Recurrence

Interventions

ledipasvir; Sofosbuvir; Ribavirin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Ribonucleosides; Nucleosides

Study Officials

• Yi-Hsiang Huang, MD, PhD

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Yi-Hsiang Huang

Study Record Dates

• First Submitted: October 30, 2016
• First Posted: November 9, 2016
• Study Start: November 1, 2016
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 7, 2017

Record last verified: 2017-08