A Single-Arm, Open-Label Phase 2 Study of JX 594 (Thymidine Kinase-Deactivated Vaccinia Virus Plus GM-CSF) Administered by Weekly Intravenous (IV) Infusions in Sorafenib-naïve Patients With Advanced Hepatocellular Carcinoma (HCC)
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
CT scans every six weeks until documented progression or date of death, whichever comes first, assessed up to 104 weeks.
CT scans evaluated at Weeks 6, 12, 18, 24, 30, 36, 42, 48
James Burke, MD
United States: Food and Drug Administration
|University of Texas Health Science Center at San Antonio||San Antonio, Texas 78284-7811|
|Mayo Clinic||Scottsdale, Arizona|