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
KEY
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Survival
Determine overall survival for patients receiving JX-594 plus best supportive care (Arm A) compared with those patients receiving best supportive care (Arm B) in patients with advanced hepatocellular carcinoma (HCC) who have failed sorafenib treatment.
CT scan every six weeks until progression or death, assessed up to 21 months
No
James Burke, MD
Study Director
Jennerex Biotherapeutics
United States: Food and Drug Administration
JX594-HEP018
NCT01387555
August 2011
October 2014
Name | Location |
---|---|
Chao Family Comprehensive Cancer Center | Orange, California 92868 |
Montefiore Medical Center | Bronx, New York 10467-2490 |
University of Chicago Medical Center | Chicago, Illinois 60637 |
California Pacific Medical Center | San Francisco, California 94115 |
Gabrail Cancer Center | Canton, Ohio 44718 |
Stanford Hospital and Clinics | Stanford, California 94305 |
Billings Clinic | Billings, Montana 59107-7000 |
Moores University of California San Diego Cancer Center | LA Jolla, California 92093 |
University Hospitals Case Medical Center | Cleveland, Ohio 44106 |
The Methodist Hospital Department of Surgery | Houston, Texas 77030 |
Saint Joseph's Hospital | Paterson, New Jersey |