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HCV, HCCZEPATIERNCT03110055

the Effect of Grazoprevir/Elbasvir and TACE vs. TACE Alone in Prolonging Survival of Patients With Non-resectable HCV Associated HCC.

A study testing Grazoprevir/Elbasvir, Medical records and Transarterial Chemoembolization in people with HCV, HCC, run by Tel-Aviv Sourasky Medical Center.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Hepatocellular carcinoma (HCC) is the fifth most common cancer and the second leading cause of cancer-related deaths in the world. Hepatitis C virus (HCV) is the most common underlying cause of cirrhosis and HCC in the western world. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
HCV, HCC
What is being tested?
Grazoprevir/Elbasvir, Medical records and Transarterial Chemoembolization
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
1 May 2017to 1 May 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with chronic HCV genotype 1 (a and b) infection and un-resectable HCC who are eligible for TACE
  • Ages 18-75 years
  • Willing to take part in a clinical trial and have signed an informed consent
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less
  • Child-Pugh liver function class A
  • Patients with expected survival of less than 1 year
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  • Adequate hematologic function (plt≥60, 000 /L; Hb≥8.5 g/dl; and INR≤1.7
  • Adequate hepatic function (albumin ≥3.5 g/dl; total bilirubin, ≤2 mg/dl; ALT and AST ≤5 times the upper limit of the normal range)
  • Adequate renal function (serum creatinine ≤1.5 times the upper limit of normal range).

Who cannot join

  • Patients unwilling to sign the informed consent
  • Patients unwilling or not capable to complete the anti-viral treatment with Grazoprevir/Elbasvir
  • CPT score >7
  • Patients ineligible for TACE
  • Patients with contraindications to elbasvir/grazoprevir
  • Patients suffering from other underlying liver disease (HBV, HIV, PSC, PBC, AIH etc.)
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  • Patients with malignancies other than HCC
  • Patients with previous anti-HCC treatment (RFA, TACE, SIRT or sorafenib)
  • Active alcohol or substance use
  • Previous liver transplantations
  • Child Pugh B or C cirrhosis
  • Total serum bilirubin >1.9 mg/dL
  • Extra-hepatic spread (metastases)
  • Pregnant/lactating women, minors and disabled/incapacitated persons

About this study

Official title: Pilot Study to Assess the Effect of Grazoprevir/Elbasvir (ZEPATIER™) and Transarterial Chemoembolization (TACE) vs. TACE Alone in Prolonging Survival of Patients With Non-resectable HCV Associated Hepatocellular Carcinoma

Hepatocellular carcinoma (HCC) is the fifth most common cancer and the second leading cause of cancer-related deaths in the world. Hepatitis C virus (HCV) is the most common underlying cause of cirrhosis and HCC in the western world. Most patients with HCC present with either non-resectable tumor and/or severe underlying liver dysfunction, and are not suitable candidates for curative treatments by resection or transplantation. Thus, for the majority of patients with HCV related HCC, the only option is prolongation of life without a chance for cure. These patients generally have a poor prognosis with a median survival of less than 1 year. Arterial obstruction of branches of the hepatic artery and simultaneous infusion of chemotherapy (Trans-arterial chemo-embolization or TACE) induces ischemic tumor necrosis with a high rate of objective tumor responses (30-60%). Overall, the median survival after TACE for intermediate HCC is about 20 months, an improvement over supportive care. Treatment with Grazoprevir/Elbasvir showed excellent results in phase 3 studies for patients with HCV genotype 1 (a and b) and genotype 4 infection and is approved for HCV treatment in the USA, Europe and Israel. Anti-HCV therapies may influence HCC biology by decreasing inflammation and may thus alter the tumor microenvironment.

Read the detailed description

Single center, open label, prospective pilot study. The study will include 20 HCV genotype 1 (a and b) cirrhotic patients (Child Pugh A compensated cirrhosis) with advanced, un-resectable HCC who are eligible for TACE. This pilot study will have one arm which will be compared to historical controls. All patients participating in the study will receive Grazoprevir/Elbasvir treatment according to established guidelines together with regular TACE treatments. The historical controls will refer to patients who received regular TACE treatments alone (standard of HCC care). Follow up will be for up to 24 months from TACE initiation.

Conditions
HCV, HCC
Being tested
Grazoprevir/Elbasvir, Medical records, Transarterial Chemoembolization
Medical subject headings
Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Grazoprevir/ElbasvirDrug

    anti-viral treatment for HCV

  • Medical recordsOther

    Medical records of patients who underwent Transarterial Chemoembolization only, in the past.

  • Transarterial ChemoembolizationProcedure or surgery

    A minimally invasive procedure performed in interventional radiology to restrict a tumor's blood supply. Small embolic particles coated with chemotherapeutic drugs are injected selectively through a catheter into an artery directly supplying the tumor. These particles both block the blood supply and induce cytotoxicity, attacking the tumor in several ways.

Study groups in NCT03110055
Study groupRoleWhat they receive
HCV patients with un-resectable HCCExperimentalHCV genotype 1 (a and b) cirrhotic patients (child pugh A compensated cirrhosis) with advanced and un-resectable HCC who are eligible for TACE . The patients will receive Grazoprevir/Elbasvir and Transarterial Chemoembolization. Their outcomes will be compared to the medical records of patients who underwent Transarterial Chemoembolization only, in the past.
Receives: Drug: Grazoprevir/Elbasvir; Other: Medical records; Procedure: Transarterial Chemoembolization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    15% or more increase in survival with the combination treatment of Grazoprevir/Elbasvir and TACE vs. historical control of TACE alone; Time Frame: from start of treatment to death from any cause, or last known date of survival

    Measured: assessed up to 24 months

  2. Adverse events and serious adverse events (AEs, SAEs)

    will be assessed in all patients receiving at least one dose of a combination therapy, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

    Measured: 24 months

  3. Time to progression (TTP)

    Time from start of treatment until the first documented event of symptomatic progression.

    Measured: Assessed, up to 24 months

  4. SVR12 rates

    : proportion of patients achieving SVR12

    Measured: 12 weeks after the last actual dose of Grazoprevir/Elbasvir

  5. Hepatic de-compensation as assessed by clinical end-points

    development of ascites, and will undergo repeated liver function tests every 2 weeks to detect CPT increase.

    Measured: Once a month up to 24 months

Secondary outcomes (5)

  1. Time to radiologic progression

    a decrease in tumor in 15 % or more of the patients undergoing combination therapy vs. historical control of TACE alone

    Measured: The time from start of treatment to disease progression, according to mRECIST, assessed up to 24 months.

  2. Disease-control rate

    The percentage of patients who had a best-response rating of complete response, partial response, or stable disease (according to mRECIST) that was maintained for at least 28 days after the first demonstration of that rating on the basis of independent radiologic review

    Measured: at least 28 days after the first demonstration of that rating on the basis of independent radiologic review

  3. decrease in tumor markers

    A 50 % decrease in tumor markers in 15 % or more patients undergoing combination therapy vs. TACE alone

    Measured: Screening and 24 months.

  4. quality of life

    Assess quality of life as measured by SF-36 questionnaire

    Measured: At screening, and months 3,13,22.

  5. Symptom severity score

    Assess severity of symptoms as measured by FSHI8 questionnaire

    Measured: At screening, and months 3,13,22.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2017
  2. Study start1 May 2017 (estimated)
  3. Primary completion1 May 2018 (estimated)
  4. Study completion1 May 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is a single center, open label, prospective pilot study. The study will enroll 20 HCV genotype 1 cirrhotic patients with advanced and un-resectable HCC who are eligible for TACE. The patients will receive Grazoprevir/Elbasvir anti-viral treatment in accordance with established guidelines together with regular TACE treatments. Follow up will be for up to 24 months from TACE initiation.
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03110055
Sponsor's protocol ID
TASMC-16-OS-0702-CTIL
Acronym
ZEPATIER
Status last verified
Apr 2017
First submitted
8 Feb 2017
Last updated
12 Apr 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Grazoprevir/Elbasvir, Medical records and Transarterial Chemoembolization in people with HCV, HCC, run by Tel-Aviv Sourasky Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: assessed up to 24 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03110055.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2017.

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