Direct-acting Antivirals and Hepatocellular Carcinoma Recurrence

Hepatocellular Carcinoma Clinical Trial

— RECAR  

Official title:

Direct-acting Antiviral Therapy Decreases Hepatocellular Carcinoma Recurrence Rate in Cirrhotic Patients With Chronic Hepatitis C

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03197155
• Other study ID #: 69HCL17_0400
• Status: Completed
• Phase: N/A
• First received: June 12, 2017
• Last updated: June 21, 2017
• Start date: June 1, 2016
• Est. completion date: March 31, 2017

Study information

• Verified date: June 2017
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Background and Aims: Arrival of direct-acting antiviral (DAA) agents against hepatitis C virus (HCV) with high-sustained virological response (SVR) rates and very few side effects has drastically changed the management of HCV infection. The impact of DAA exposure on hepatocellular carcinoma (HCC) recurrence after a first remission in patients with advanced fibrosis remains to be clarified.

Methods: 68 consecutive HCV patients with a first HCC diagnosis and under remission, subsequently treated or not with a DAA combination, were included. Clinical, biological, and virological data were collected at first HCC diagnosis, at remission and during the surveillance period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: March 31, 2017
• Est. primary completion date: January 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• first HCC diagnosed by invasive or non-invasive criteria following the American Association for the Study of Liver Diseases (AASLD) guidelines during the study time horizon

• complete remission after hepatocellular carcinoma treatment defined by the European Association for the Study of the Liver (EASL) criteria as absence of residual tumor/complete necrosis at imaging one month after the end of hepatocellular carcinoma treatment

Exclusion Criteria:

• prior history of hepatocellular carcinoma before January 2009

• liver transplantation before hepatocellular carcinoma diagnosis

• presence of "non-characterized nodules" after hepatocellular carcinoma treatment at imaging

• history of direct-acting antivirals treatment before the first hepatocellular carcinoma diagnosis

• hepatic decompensation

• human immunodeficiency virus (HIV) coinfection.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Direct Acting Antivirals
• Hepatitis
• Hepatitis C
• Hepatocellular Carcinoma
• Recurrence

Intervention

Drug:
• Direct Acting Antivirals against hepatitis C virus infection
The cohort includes cirrhotic patients infected with HCV and successfully treated for their first history of hepatocellular carcinoma. Some of these patients were treated with direct-acting antivirals for their HCV infection while the others did not receive any direct-acting antivirals treatment during the follow-up period.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hepatocellular recurrence event	The primary outcome (hepatocellular recurrence event) is evaluated using imaging surveillance data at different time points during follow-up (every 3 months within the first year following HCC remission and every 3 to 6 months thereafter) after the first HCC remission.	From date of HCC remission until the date of HCC recurrence, assessed up to January 1st, 2017