A Phase 2b Randomized Trial of JX-594 (Vaccinia GM-CSF / TK-deactivated Virus) Plus Best Supportive Care Versus Best Supportive Care in Patients With Advanced Hepatocellular Carcinoma Who Have Failed Sorafenib Treatment
This study is to determine whether JX-594 (Pexa-Vec) plus best supportive care is more effective in improving survival than best supportive care in patients with advanced Hepatocellular Carcinoma (HCC) who have failed sorafenib.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- Lawrence "Rusty" Hofmann, MD
- David Hovsepian, MD
- Aya Kamaya, MD
- Gloria Hwang, MD
- John D. Louie, MD
- WILLIAM T. KUO, MD, FSIR, FCCP, FSVM, FCIRSE
- Nishita Kothary, MD
- biological : JX-594 recombinant vaccina GM-CSF
- other : Best Supportive Care
Phase: Phase 2
Ages Eligible For Study:
- Diagnosis of primary HCC by tissue biopsy (histological/cytological diagnosis), or clinical diagnosis - Previously treated with sorafenib for ? 14 days and has discontinued sorafenib treatment at least 14 days prior to randomization due to either intolerance or radiographic progression NOTE: Sorafenib is NOT required to be the most recent treatment received for HCC - ECOG performance status 0, 1 or 2 - Child-Pugh Class A; or Child-Pugh Class B7 without clinically significant ascites - Hematocrit ?30% or Hemoglobin ?10 g/dL - Tumor status: Measurable viable tumor in the liver and injectable under imaging-guidance; At least one tumor in the liver that has not received prior local-regional treatment OR that has exhibited >25% growth in viable tumor size since prior local-regional treatment. KEY