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A Phase 2b Study of Modified Vaccinia Virus to Treat Patients Advanced Liver Cancer Who Failed Sorafenib
Sponsor: Jennerex Biotherapeutics
Summary
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.
Official title: 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 Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
129
Start Date
2011-10-08
Completion Date
2013-10-01
Last Updated
2026-07-08
Healthy Volunteers
No
Conditions
Interventions
JX-594 recombinant vaccina GM-CSF
Patients will be randomised 2:1 to Arm A or Arm B and will receive 6 treatments on days 1, 8, 22, week 6, week 12, and week 18 plus best supportive care as needed.
Best Supportive Care
Patients will be randomised 2:1 to Arm A or Arm B and will receive best supportive care as needed.
Locations (38)
Moores University of California San Diego Cancer Center
La Jolla, California, United States
Chao Family Comprehensive Cancer Center
Orange, California, United States
California Pacific Medical Center
San Francisco, California, United States
Stanford Hospital and Clinics
Stanford, California, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Billings Clinic
Billings, Montana, United States
Saint Joseph's Hospital
Paterson, New Jersey, United States
Montefiore Medical Center
The Bronx, New York, United States
Gabrail Cancer Center
Canton, Ohio, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
The Methodist Hospital Department of Surgery
Houston, Texas, United States
University of Alberta
Edmonton, Alberta, Canada
University of British Columbia
Vancouver, British Columbia, Canada
Juravinski Cancer Centre
Hamilton, Ontario, Canada
Ottawa Hopsital Research Institute
Ottawa, Ontario, Canada
Hôpitaux Universitaires de Strasbourg - Hôpital Civil
Strasbourg, Alsace, France
Centre Hospitalier Universitaire Hôpital Saint André
Bordeaux, Aquitaine, France
Hôpital de la Croix Rousse
Lyon, Auvergne-Rhône-Alpes, France
CHU d'Estaing
Clermont-Ferrand, Auvergne, France
Hôpital Purpan
Toulouse, Midi-Pyrenees, France
Hôpital Saint Antoine, CPP Ile de France V
Paris, Île-de-France Region, France
Klinikum Rechts der Isar der Technischen Universität München
München, Bavaria, Germany
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany
Johannes Gutenberg-Universität Mainz
Mainz, Rhineland-Palatinate, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Queen Mary Hospital
Hong Kong, Hong Kong
Korea University Ansan Hospital
Ansan-si, Gyeonggi-do, South Korea
Kyungpook National University Hospital
Daegu, South Korea
Pusan National University Hospital
Pusan, South Korea
Asan Medical Center
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital,Yonsei University Health System
Seoul, South Korea
Pusan National University Yangsan Hospital
Yangsan, South Korea
National Cheng-Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan