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Klinische Studien

PHOCUS

PrüfplancodeISRCTNEudraCTClinicaltrials.govDRKS
JX594-HEP0242014-001985-86NCT02562755

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

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.. ]

Diagnose

  • Leberzellkarzinom
  • Karzinom, Hepatozellulär

Hepatocellular Carcinoma (HCC)

Studiendesign

  • Phase III
  • Multizentrisch
  • Randomisiert

Intervention

Biological: Pexastimogene Devacirepvec (Pexa Vec) Drug: Sorafenib

Dokumente (passwortgeschützt)

Zuständigkeiten Gesamtstudie

SillaJen, Inc.

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