Effect of DAAs on Behavior of HCC in HCV Patients

July 19, 2021 updated by: Mohamed Alboraie, Al-Azhar University

Effect of Direct Acting Antiviral Agents on Behavior of Hepatocellular Carcinoma and Overall Survival in Patients With Chronic Hepatitis C

Investigators aim to study the effect of direct acting antiviral agents (DAAs) on behavior of hepatocellular carcinoma (HCC) and overall survival in patients with chronic hepatitis C (CHC).

Study Overview

Status

Completed

Detailed Description

Introduction:

Chronic hepatitis C (HCV) infection can be complicated with liver cirrhosis and subsequently hepatocellular carcinoma (HCC). HCC develops at an annual rate of 1% to 4%, although higher rates up to 7% have been reported in Japan. Recently; Reig et al; noticed that there was an unexpected high rate of early tumor recurrence in patients with HCV-related HCC undergoing interferon-free therapy (1). After this report; many publications have discussed the issue of HCC development and recurrence in HCV patients treated with interferon free regimens. Results of these trials are controversial with no definite conclusion till today. There is an unmet need for further study the effect of interferon free regimens on development of de novo HCC, recurrence of HCC and behavior of HCC in chronic HCV patients.

Aim of the study:

Investigators aim to study the effect of direct acting antiviral agents (DAAs) on behavior of hepatocellular carcinoma (HCC) and overall survival in patients with chronic hepatitis C (CHC).

Materials & methods:

Study Design: Prospective case control study

  • Setting: Multicenter study
  • Patients: 300 patients will be recruited in 2 groups assignment .
  • Methods:

Procedure of data collection

The following data will be collected at base line for each patient:

  1. Medical history: including current and previous treatment with stress on History of treatment by DAAs (date started, used regimen, duration of treatment and treatment response)
  2. Full clinical examination
  3. Laboratory Investigations:

    1. Complete blood picture (CBC):
    2. Liver profile: alanine aminotransferase (ALT), aspartate aminotransferase (AST), albumin, total and direct bilirubin, prothrombin time and international normalized ratio.
    3. Renal profile: serum blood urea nitrogen (BUN), creatinine, sodium and potassium levels.
    4. Hepatitis markers: hepatitis B surface antigen (HBs Ag) and hepatitis C virus antibody (HCV Ab).
    5. Alpha feto protein (AFP)
    6. Tri-Phasic spiral abdominal CT: to diagnose HCC by typical vascular pattern and to assess tumor extension.
    7. Biopsy if needed After confirming HCC diagnosis, included patients will be classified according to barcelona clinic liver cancer (BCLC) staging system and standard of care treatment will be provided to patients with different stages according to BCLC guidelines.

Follow up schedule:

Patients will be followed by CT scan or MRI examination and routine liver tests including AFP every 3 months during the first 2 years then every 6 months during the subsequent 3 years if no evidence of HCC recurrence during the first 2 years' period (for all patients regardless HCC treatment receipt and its type). Local recurrence will be defined as reappearance of tumor adjacent to the treated site of the initial HCC and distant recurrence as the emergence of one or several tumor(s) not adjacent to the treated zone. Criteria for the diagnosis of HCC recurrence will be the same as initial HCC, i.e. presence of typical hallmark of HCC according to European Association for the Study of the Liver - European Organisation for Research and Treatment of Cancer (EASL-EORTC) guidelines and defined by presence on imaging of hyper vascular in the arterial phase with washout in the portal venous or delayed phases. All imaging exams will be centralized and assessed by the same radiologist.

Analysis of results:

- Statistical analysis will aim at identifying factors leading to change of behavior of HCC after DAAs in CHC patients in addition to determination of the overall survival in those patients.

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Cairo, Egypt, 11651
        • MOHAMED Alboraie
      • Cairo, Egypt
        • Helwan University
      • Cairo, Egypt
        • National Hepatology and Tropical Medicine Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with HCV related Hepatocellular carcinoma (HCC)

Description

Inclusion Criteria:

  • Patients with HCV related Hepatocellular carcinoma (HCC); all patients with confirmed diagnosis of HCC according to EASL-EORTC guidelines who attend HCC outpatient clinics in the study centers will be enrolled after signing informed consent. Patients will be then assigned into two main comparison groups:
  • Group I: HCC patients who received DAAs for chronic HCV previously (either responders or not)
  • Group II: HCC patients who are naive to DAAs.

Exclusion Criteria:

  • Patients who refuse to be enrolled in the study.
  • Patients with hepatitis B virus or any other causes of cirrhosis.
  • Other prior malignancy without complete remission in the last five years, with the exception of adequately treated basal cell carcinoma or in situ cervical cancer; in case of other prior malignancy, the diagnosis of HCC has to be histologically proven.
  • HCC developed on transplanted liver.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Group I
HCC patients who received DAAs for chronic HCV previously (either responders or not)
Group II
HCC patients who are naive to DAAs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 6 months - 3 years
he length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.
6 months - 3 years
Behavior of hepatocellular carcinoma
Time Frame: 6 months - 3 years
Early recurrence, or rapid progression
6 months - 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: 6 months - 3 years
The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. Progression-free survival (PFS) will be measured by the Independent Radiological Review according to RECIST 1.1.
6 months - 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mohamed Alboraie, M.D., Al-Azhar University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2018

Primary Completion (Actual)

June 19, 2021

Study Completion (Actual)

July 19, 2021

Study Registration Dates

First Submitted

June 24, 2017

First Submitted That Met QC Criteria

June 24, 2017

First Posted (Actual)

June 27, 2017

Study Record Updates

Last Update Posted (Actual)

July 21, 2021

Last Update Submitted That Met QC Criteria

July 19, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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