last updated at 19.10.2019

PHOCUS

A Phase 3 Randomized, Open-Label Study Comparing Pexa-Vec (Vaccinia GM-CSF / Thymidine Kinase-Deactivated Virus) Followed by Sorafenib Versus Sorafenib in Patients with Advanced Hepatocellular Carcinoma (HCC) Without Prior Systemic Therapy

Status: Aktiv

ISRCTN EudraCT Clinicaltrials.gov DRKS
2014-001985-86 NCT02562755

Diagnose

  • Hepatozelluläres Karzinom (Leberzellkarzinom)
  • Karzinom
  • Hepatozellulär

Studienziel / Fragestellung

Primäres Prüfziel
  • Overall Survival [ Time Frame: From the date of randomization to the date of death due to any cause up to study completion (approximately 53 months)

Sekundäre Prüfziele
  • Time to Progression (TTP) [ Time Frame: From date of randomization to the date of first documented radiographic tumor progression up to 53 months. ] Progression Free Survival (PFS) [ Time Frame: From date of randomization to the date of first documented radiographic tumor progression or death

  • whichever occurs first
  • assessed up to 53 months. ] Overall Response Rate (ORR) [ Time Frame: From the date of randomization until disease progression
  • up to 53 months. ] Disease Control Rate (DCR) [ Time Frame: From date of randomization to end of participation in the study up to 53 months. ] Proportion of patients whose best overall response during their participation in the study is either CR
  • PR
  • or stable disease (SD). Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) [ Time Frame: From date of randomization to end of participation in the study
  • up to 53 months. ] Assessed by the NCI CTCAE (version 4.03). Incidence of AEs and SAEs will be reported. Time to Symptomatic Progression (TSP) [ Time Frame: Time from randomization until the first documented event of symptomatic progression
  • up to 53 months.. ]

Patientenmerkmale

Alter

-

Studiendesign

  • Multizentrisch
  • Phase III
  • Randomisiert

Intervention

Biological: Pexastimogene Devacirepvec (Pexa Vec) Drug: Sorafenib

Dokumente (passwortgeschützt)

Zuständigkeiten Gesamtstudie

Sponsor

  • SillaJen
  • Inc.

Prüfzentrum 1

 

  • Medizinische Klinik III Klinik für Gastroenterologie
  • Stoffwechselerkrankungen und Internistische Intensivmedizin

Prüfer (Hauptprüfer im Zentrum)

Univ.-Prof. Dr. med. Christian Trautwein

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