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Carcinoma, HepatocellularPhase 2NCT01171651

A Study of Pexa-Vec (JX-594) Prior to Sorafenib to Treat Unresectable Primary Hepatocellular Carcinoma

A Phase 2 study testing JX-594 and Sorafenib in people with Carcinoma, Hepatocellular, run by Jennerex Biotherapeutics at 2 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Hepatocellular
What is being tested?
JX-594 and Sorafenib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
2 sitesSouth Korea
Study dates
26 May 2009to 27 Sep 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histological confirmation or clinical/laboratory diagnosis of primary hepatocellular carcinoma (HCC)
  • Cancer is not surgically resectable for cure
  • Child Pugh A or B
  • Performance Score: KPS score of ≥ 70
  • Platelet count ≥ 50,000 plts/mm3
  • Total bilirubin ≤ 2.5 x ULN
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  • AST, ALT < 5.0 x ULN
  • Acceptable coagulation status: INR ≤ 1.5 x ULN
  • Acceptable kidney function: Serum creatinine < 2.0 mg/dL
  • Sorafenib naive or refractory to sorafenib therapy Tumor Status: At least one intrahepatic tumor, and at least ≥50% of the total intrahepatic viable tumor mass, measurable by CT and injectable under imaging-guidance (note: injected and/or viable tumors must be previously untreated or ≥20% increase in size since preceding local-regional treatment).

Who cannot join

  • Known contraindications to sorafenib
  • Pregnant or nursing an infant
  • Significant immunodeficiency due to underlying illness (e.g. hematological malignancies, congenital immunodeficiencies and/or HIV infection/AIDS) and/or medication (e.g. high-dose systemic corticosteroids)
  • History of exfoliative skin condition (e.g. severe eczema, ectopic dermatitis, or similar skin disorder) that at some stage has required systemic therapy
  • Clinically significant and/or rapidly accumulating ascites, peri-cardial and/or pleural effusions
  • Severe or unstable cardiac disease
Show all 14Show fewer
  • Current, known CNS malignancy
  • Use of anti-platelet or anti-coagulation medication
  • Use of the following anti-viral agents: ribavirin, adefovir, cidofovir (within 7 days prior to the first treatment), and PEG-IFN (within 14 days prior to the first treatment).
  • Patients with household contacts who meet any of these criteria unless alternate living arrangements can be made during the patient's active dosing period and for 7 days following the last dose of study medication:
  • Pregnant or nursing an infant
  • Children < 12 months old
  • History of exfoliative skin condition that at some stage has required systemic therapy
  • Significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

  • Pusan National University Hospital

    Busan

  • Pusan National University Yangsan Hospital

    Yangsan

Other trials in South Korea

About this study

Official title: A Phase 2 Open-Label Pilot Safety Study of JX-594 Administered by IV Infusion Followed by Intratumoral Injection Prior to Standard Sorafenib Treatment in Patients With Unresectable Primary Hepatocellular Carcinoma

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.

Read the detailed description

This is a Phase 2, open-label, pilot safety study designed to evaluate the safety and tolerability of sequential therapy consisting of Pexa-Vec (JX-594) followed by standard sorafenib in patients with advanced, unresectable primary hepatocellular carcinoma (HCC).

Patients will receive an initial intravenous (IV) infusion of Pexa-Vec at a dose of 1 x 10^9 plaque-forming units (pfu) on Day 1. This is followed by two intratumoral (IT) injections of Pexa-Vec on Day 8 and Day 22, each at a total dose of 1 x 10^9 pfu divided among 1 to 5 hepatic tumors. Starting on Day 25 (approximately 3 days after the final regular dose of Pexa-Vec), patients will initiate standard oral sorafenib therapy twice daily. For patients with viable hepatic tumor tissue at Week 12, an optional additional IT dose of Pexa-Vec may be administered.

The primary objective of this study is to assess the safety and toxicity of this sequential regimen, determined by the incidence of treatment-related Grade 3 and Grade 4 adverse events (AEs) and treatment-related serious adverse events (SAEs). Secondary objectives include evaluating the disease control rate (DCR) at 12 weeks, overall survival (OS) time, and radiographic response rate based on modified RECIST (mRECIST 1.0) and/or Choi criteria.

Being tested
JX-594, Sorafenib
Keywords
Vaccinia, Vaccinia Virus, JX-594, Jennerex, Primary Hepatocellular Carcinoma, Primary Liver Cancer, Liver Cancer, Sorafenib, Nexavar, Pexa-Vec
Medical subject headings
Carcinoma, Hepatocellular, Vaccinia, Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JX-594Biological

    Also called Pexa-Vec, Pexastimogene Devacirepvec, VACC-6.25.1, Recombinant Vaccinia GM-CSF

    Patients will receive a total dose of 1e9 pfu per treatment starting with one IV dose on Day 1 and injected intratumorally in 1-5 intrahepatic tumors on Day 8 and 22. An optional maintenance JX-594 dose may be given intratumorally at Week 12.

  • SorafenibDrug

    Also called Nexavar

    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. Sorafenib therapy is briefly interrupted if an optional Week 12 JX-594 dose is given.

Study groups in NCT01171651
Study groupRoleWhat they receive
JX-594 followed by sorafenibExperimental1e9 pfu (plaque-forming units) total JX-594 dose on each of up to four (4) JX-594 treatment days. Sorafenib is initiated after 3 JX-594 treatments and briefly interrupted if an optional 4th JX-594 treatment is given.
Receives: Biological: JX-594; Drug: Sorafenib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Treatment-Related Grade 3 and Grade 4 Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Safety and toxicity will be determined by the incidence of treatment-related Grade 3 and Grade 4 AEs and treatment-related SAEs. Adverse events will be collected and assessed through 28 days after the 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).

    Measured: Safety evaluations through 28 days after last dose of JX-594

Secondary outcomes (3)

  1. Number of Participants Achieving Disease Control (DCR) at 12 Weeks

    Disease Control Rate (DCR) is defined as the percentage of participants achieving a confirmed complete response (CR), partial response (PR), or stable disease (SD), with tumor responses assessed based on modified RECIST (mRECIST 1.0) and/or Choi criteria. Per mRECIST 1.0 for target tumors, CR indicates the disappearance of all tumor(s), PR indicates a >=30% decrease in the sum of the longest diameters (LD) of tumor(s) referenced to Baseline, and SD represents any case that does not qualify for either PR or progressive disease (PD, which is a >=20% increase in the sum of LDs). Additionally, per Choi criteria, a response is defined as a >=10% decrease in the LD of the tumor and/or a >=15% decrease in the average tumor density measured in Hounsfield Units on a CT scan.

    Measured: 12 weeks from first JX-594 dose

  2. Determine Radiographic Response Rate

    Response rate evaluation based on modified RECIST and/or Choi response criteria

    Measured: Periodically throughout study participation (average of up to 1 year)

  3. Overall Survival (OS)

    Overall survival (OS) is defined as the time from the first dose of Pexa-Vec treatment until death from any cause. For patients not known to have died at the time of the analysis, OS was censored on the date they were last known to be alive. Data were summarized using the Kaplan-Meier method.

    Measured: From the date of first treatment until death from any cause, assessed up to approximately 40 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2010 (estimated)
  2. Study start26 May 2009
  3. Primary completion27 Sep 2012
  4. Study completion27 Sep 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01171651
Sponsor's protocol ID
JX594-HEP016
Status last verified
Jul 2026
First submitted
26 Jul 2010
Last updated
14 Jul 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Breitbach CJ, Arulanandam R, De Silva N, Thorne SH, Patt R, Daneshmand M, Moon A, Ilkow C, Burke J, Hwang TH, Heo J, Cho M, Chen H, Angarita FA, Addison C, McCart JA, Bell JC, Kirn DH. Oncolytic vaccinia virus disrupts tumor-associated vasculature in humans. Cancer Res. 2013 Feb 15;73(4):1265-75. doi: 10.1158/0008-5472.CAN-12-2687. Epub 2013 Feb 7.

    PubMed 23393196

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JX-594 and Sorafenib in people with Carcinoma, Hepatocellular, run by Jennerex Biotherapeutics at 2 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-Related Grade 3 and Grade 4 Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Safety evaluations through 28 days after last dose of JX-594). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01171651, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.

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