Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

11 april 2017 uppdaterad av: michal roll, Tel-Aviv Sourasky Medical Center

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.

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Förväntat)

20

Fas

  • Inte tillämpbar

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Läkemedel: Grazoprevir/Elbasvir
anti-viral treatment for HCV
Övrig: Medical records
Medical records of patients who underwent Transarterial Chemoembolization only, in the past.
Procedur: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Overall survival
Tidsram: 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
assessed up to 24 months
Adverse events and serious adverse events (AEs, SAEs)
Tidsram: 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
24 months
Time to progression (TTP)
Tidsram: Assessed, up to 24 months
Time from start of treatment until the first documented event of symptomatic progression.
Assessed, up to 24 months
SVR12 rates
Tidsram: 12 weeks after the last actual dose of Grazoprevir/Elbasvir
: proportion of patients achieving SVR12
12 weeks after the last actual dose of Grazoprevir/Elbasvir
Hepatic de-compensation as assessed by clinical end-points
Tidsram: Once a month up to 24 months
development of ascites, and will undergo repeated liver function tests every 2 weeks to detect CPT increase.
Once a month up to 24 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Time to radiologic progression
Tidsram: 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
The time from start of treatment to disease progression, according to mRECIST, assessed up to 24 months.
Disease-control rate
Tidsram: 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
at least 28 days after the first demonstration of that rating on the basis of independent radiologic review
decrease in tumor markers
Tidsram: Screening and 24 months.
A 50 % decrease in tumor markers in 15 % or more patients undergoing combination therapy vs. TACE alone
Screening and 24 months.
quality of life
Tidsram: At screening, and months 3,13,22.
Assess quality of life as measured by SF-36 questionnaire
At screening, and months 3,13,22.
Symptom severity score
Tidsram: At screening, and months 3,13,22.
Assess severity of symptoms as measured by FSHI8 questionnaire
At screening, and months 3,13,22.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Tel-Aviv Sourasky Medical Center

Samarbetspartners

Merck Sharp & Dohme LLC

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Förväntat)

1 maj 2017

Primärt slutförande (Förväntat)

1 maj 2018

Avslutad studie (Förväntat)

1 maj 2019

Studieregistreringsdatum

Först inskickad

8 februari 2017

Först inskickad som uppfyllde QC-kriterierna

11 april 2017

Första postat (Faktisk)

12 april 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

12 april 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

11 april 2017

Senast verifierad

1 april 2017

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • TASMC-16-OS-0702-CTIL

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på HCV, HCC

Kliniska prövningar på Grazoprevir/Elbasvir

Sök liknande försök

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

CROs by country

CROs in Poland

Betingelser

Sällsynta sjukdomar

Läkemedelsinterventioner

Kosttillskott

Sponsor / medarbetare

Platser

Prenumerera