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

NCT ID: NCT03110055

Last Updated: 2017-04-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2019-05-01

Brief 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. 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HCV patients with un-resectable HCC

HCV 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.

Group Type: EXPERIMENTAL

Grazoprevir/Elbasvir

Intervention Type: DRUG

anti-viral treatment for HCV

Medical records

Intervention Type: OTHER

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

Transarterial Chemoembolization

Intervention Type: PROCEDURE

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.

Interventions

Grazoprevir/Elbasvir

anti-viral treatment for HCV

Intervention Type: DRUG

Medical records

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

Intervention Type: OTHER

Transarterial Chemoembolization

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Patients with chronic HCV genotype 1 (a and b) infection and un-resectable HCC who are eligible for TACE

2. Ages 18-75 years

3. Willing to take part in a clinical trial and have signed an informed consent

4. Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less

5. Child-Pugh liver function class A

6. Patients with expected survival of less than 1 year

7. Adequate hematologic function (plt≥60, 000 /L; Hb≥8.5 g/dl; and INR≤1.7

8. 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)

9. Adequate renal function (serum creatinine ≤1.5 times the upper limit of normal range).

Exclusion Criteria

1. Patients unwilling to sign the informed consent

2. Patients unwilling or not capable to complete the anti-viral treatment with Grazoprevir/Elbasvir

3. CPT score >7

4. Patients ineligible for TACE

5. Patients with contraindications to elbasvir/grazoprevir

6. Patients suffering from other underlying liver disease (HBV, HIV, PSC, PBC, AIH etc.)

7. Patients with malignancies other than HCC

8. Patients with previous anti-HCC treatment (RFA, TACE, SIRT or sorafenib)

9. Active alcohol or substance use

10. Previous liver transplantations

11. Child Pugh B or C cirrhosis

12. Total serum bilirubin >1.9 mg/dL

13. Extra-hepatic spread (metastases)

14. Pregnant/lactating women, minors and disabled/incapacitated persons

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

michal roll

Head of Research and Development department, Principle investigator, MD.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

TASMC-16-OS-0702-CTIL

Identifier Type: -

Identifier Source: org_study_id