the Effect of Grazoprevir/Elbasvir and TACE vs. TACE Alone in Prolonging Survival of Patients With Non-resectable HCV Associated HCC. (ZEPATIER)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03110055|
Recruitment Status : Unknown
Verified April 2017 by michal roll, Tel-Aviv Sourasky Medical Center.
Recruitment status was: Not yet recruiting
First Posted : April 12, 2017
Last Update Posted : April 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|HCV, HCC||Drug: Grazoprevir/Elbasvir Other: Medical records Procedure: Transarterial Chemoembolization||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention 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)|
|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|
|Estimated Study Start Date :||May 1, 2017|
|Estimated Primary Completion Date :||May 1, 2018|
|Estimated Study Completion Date :||May 1, 2019|
Experimental: 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.
anti-viral treatment for HCV
Other: Medical records
Medical records of patients who underwent Transarterial Chemoembolization only, in the past.
Procedure: 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.
- Overall survival [ Time Frame: assessed up to 24 months ]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
- Adverse events and serious adverse events (AEs, SAEs) [ Time Frame: 24 months ]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
- Time to progression (TTP) [ Time Frame: Assessed, up to 24 months ]Time from start of treatment until the first documented event of symptomatic progression.
- SVR12 rates [ Time Frame: 12 weeks after the last actual dose of Grazoprevir/Elbasvir ]: proportion of patients achieving SVR12
- Hepatic de-compensation as assessed by clinical end-points [ Time Frame: Once a month up to 24 months ]development of ascites, and will undergo repeated liver function tests every 2 weeks to detect CPT increase.
- Time to radiologic progression [ Time Frame: The time from start of treatment to disease progression, according to mRECIST, assessed up to 24 months. ]a decrease in tumor in 15 % or more of the patients undergoing combination therapy vs. historical control of TACE alone
- Disease-control rate [ Time Frame: at least 28 days after the first demonstration of that rating on the basis of independent radiologic review ]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
- decrease in tumor markers [ Time Frame: Screening and 24 months. ]A 50 % decrease in tumor markers in 15 % or more patients undergoing combination therapy vs. TACE alone
- quality of life [ Time Frame: At screening, and months 3,13,22. ]Assess quality of life as measured by SF-36 questionnaire
- Symptom severity score [ Time Frame: At screening, and months 3,13,22. ]Assess severity of symptoms as measured by FSHI8 questionnaire