The purpose of this pilot safety study is to evaluate the safety and tolerability of JX-594 (Pexa-Vec) administered intravenously and intratumorally prior to standard sorafenib therapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Patients will receive a total dose of 1e9 per treatment starting with one IV dose on Day 1 and injected intratumorally in 1-5 intrahepatic tumors on Day 8 and 22. Starting on Day 25 (3 days after the final JX-594 dose) patients will initiate oral sorafenib therapy twice daily according to standard approved guidelines. An optional maintenance JX-594 dose may be given intratumorally at Week 12 (sorafenib briefly interrupted).
Pusan National University Hospital
Busan, South Korea
Pusan National University Yangsan Hospital
Yangsan, South Korea
Determine safety and tolerability of intravenous infusion of JX-594 followed by intratumoral injections with JX-594 prior to standard sorafenib therapy
Adverse events will be collected and assessed to assess safety and tolerability through 28 days after last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
Time frame: Safety evaluations through 28 days after last dose of JX-594
Determine Disease Control Rate (DCR) at 12 weeks
DCR: confirmed complete response, partial response or stable disease based on modified RECIST and/or Choi response criteria
Time frame: Disease control and response assessment at 12 weeks from first JX-594 dose
Determine radiographic response rate
Response rate evaluation based on modified RECIST and/or Choi response criteria
Time frame: Periodically throughout study participation (average of up to 1 year)
Determine overall survival time
Time frame: Ongoing (average of 1 year)
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