At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 30 enrolled
Drug / intervention
JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF)genetic
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II-a, Open-Label, Randomized Study of JX-594 (Thymidine Kinase-deleted Vaccinia Virus Plus GM-CSF) Administered by Intratumoral Injection in Patients With Unresectable Primary Hepatocellular Carcinoma
In Brief
A Phase 2 clinical trial evaluating JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF) for Carcinoma, Hepatocellular. Completed, enrolled 30 participants across 9 sites in 3 countries.
Detailed Summary
The purpose of this research study is to determine whether JX-594 (Pexa-Vec) has significant anti-tumoral activity and tolerability in primary hepatocellular carcinoma and to determine the dose to be used in further testing.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Hepatocellular
CountriesCanada, South Korea, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 2007
Enrollment StartAug 2008
Primary CompletionDec 2011
Study CompletionFeb 2013
TodayJul 2026
First PostedNov 6, 2007
Enrollment StartAug 1, 2008
Primary CompletionDec 1, 2011
Study CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 18.7 years ago
Interventions
JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF)genetic
Patients will be randomized 1:1 to one of two total doses (1e8 or 1e9 pfu)and injected intratumorally in 1-5 intrahepatic tumors on Days 1, 15, and 29.