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Hepatocellular Carcinoma (HCC)Phase 3PHOCUSNCT02562755

Hepatocellular Carcinoma Study Comparing Vaccinia Virus Based Immunotherapy Plus Sorafenib vs Sorafenib Alone

A Phase 3 study testing Pexastimogene Devacirepvec (Pexa Vec) and Sorafenib in people with Hepatocellular Carcinoma (HCC), run by SillaJen, Inc. at 142 sites in 16 countries.

Completed

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

Official record
Search all trials

Trial summary

This is a randomized Phase 3 study to determine whether treatment with vaccinia virus based immunotherapy (Pexa-Vec) followed by sorafenib increases survival compared to treatment with sorafenib in patients with advanced hepatocellular carcinoma who have not received prior systemic therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma (HCC)
What is being tested?
Pexastimogene Devacirepvec (Pexa Vec) and Sorafenib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
459 participants
Where
142 sitesin 16 countries
Study dates
Oct 2015to Jul 2020
Phase
Phase 3
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/cytological diagnosis of primary HCC
  • Advanced stage HCC (Barcelona Clinic Liver Cancer [BCLC] Stage C or B per American Association for the Study of Liver Disease [AASLD] guidelines)
  • At least one measurable viable tumor in the liver, ≥1 cm longest diameter (LD), using a dynamic imaging technique (arterial phase of triphasic computerized tomography [CT] scan, or dynamic contrast-enhanced magnetic resonance imaging [MRI]), and injectable under imaging-guidance (CT and/or ultrasound)
  • Child-Pugh Class A
  • Performance status 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
  • Adequate hematological, hepatic, and renal function:
  • Additional inclusion criteria exist

Who cannot join

  • Histological diagnosis of cholangiocarcinoma, hepatocholangiocarcinoma, fibrolamellar carcinoma and hepatoblastoma
  • Symptomatic cardiovascular disease, including but not limited to significant coronary artery disease (e.g., requiring angioplasty or stenting) or congestive heart failure within the preceding 12 months
  • Current or past history of cardiovascular disease (e.g.. past history of myocardial infarction, ischemic cardiomyopathy) unless cardiology consultation and clearance has been obtained for study participation
  • History of moderate or severe ascites, bleeding esophageal varices, hepatic encephalopathy or pleural effusions related to liver insufficiency within 6 months of screening
  • Bulky disease patients - tumors encompassing >50% of the liver volume and / or inferior vena cava invasion
  • Known significant immunodeficiency due to underlying illness (e.g., HIV/AIDS) and/or immune-suppressive medication including high-dose corticosteroids
Show all 9Show fewer
  • Ongoing severe inflammatory skin condition (as determined by the Investigator) requiring medical treatment
  • History of severe eczema (as determined by the Investigator) requiring medical treatment
  • Additional exclusion criteria exist

Trial locations and contacts

142 sites in 16 countries.

142 sites in 16 countries

United States23 sites

  • Mercy Medical Center, Inc.

    Baltimore, Maryland, 21202

  • Billings Clinic

    Billings, Montana, 59101

  • University of Alabama

    Birmingham, Alabama, 35294

  • University of Chicago

    Chicago, Illinois, 60637

  • Ohio State University

    Columbus, Ohio, 43210

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • University of Florida Shands Hospital

    Gainesville, Florida, 32608

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66205

  • Kansas City Research Institute

    Kansas City, Missouri, 64131

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • University of Louisville

    Louisville, Kentucky, 40202

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Morristown Medical Center

    Morristown, New Jersey, 07960

  • Tulane University Health Sciences Center

    New Orleans, Louisiana, 70112

  • UC Irvine Medical Center

    Orange, California, 92868

  • Stanford University School of Medicine

    Palo Alto, California, 94304

  • St. Joseph's Hospital

    Paterson, New Jersey, 07503

  • Hospital of The University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Mayo Clinic Arizona

    Scottsdale, Arizona, 85259

  • Benaroya Research Institute at Virginia Mason Hospital

    Seattle, Washington, 98101

  • Saint Louis University

    St Louis, Missouri, 63104

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

South Korea21 sites

  • Site No. 8208

    Ansan

  • Site No. 8211

    Bucheon-si

  • Site No. 8201

    Busan

  • Site 8216

    Daegu

  • Site No. 8207

    Daegu

  • Site No. 8213

    Daegu

  • Site No. 8220

    Daegu

  • Site 8224

    Goyang

  • Site No. 8221

    Jinju

  • Site No. 8218

    Pusan

  • Site No. 8222

    Seongnam

  • Site No. 8219

    Seongnam-si

  • Site No. 8202

    Seoul

  • Site No. 8203

    Seoul

  • Site No. 8205

    Seoul

  • Site No. 8209

    Seoul

  • Site No. 8212

    Seoul

  • Site No. 8215

    Seoul

  • Site No. 8223

    Seoul

  • Site No. 8210

    Suwon

  • Site No. 8217

    Ulsan

Other trials in South Korea

China19 sites

  • Site 8829

    Changchun

  • Site No. 8821

    Changsha

  • Site 8811

    Fuzhou

  • Site 8820

    Fuzhou

  • Site No.8816

    Guangdong

  • Site 8827

    Guangzhou

  • Site No.8828

    Guangzhou

  • Site 8832

    Hangzhou

  • Site No. 8802

    Harbin

  • Site 8805

    Hefei

  • Site No. 8808

    Hefei

  • Site No.8815

    Hefei

  • Site No. 8801

    Nanjing

  • Site 8833

    Qingdao

  • Site 8806

    Shanghai

  • Site 8822

    Shanghai

  • Site 8831

    Shanghai

  • Site No. 8823

    Xi'an

  • Site No. 8825

    Xi'an

Other trials in China

Australia13 sites

  • Site No. 8409

    Adelaide

  • Site No. 8412

    Adelaide

  • Site No. 8403

    Brisbane

  • Site No. 8401

    Camperdown

  • Site No. 8407

    Clayton

  • Site No. 8406

    Concord

  • Site No. 8408

    Fitzroy

  • Site No. 8405

    Footscray

  • Site No. 8414

    Heidelberg

  • Site No. 8411

    Melbourne

  • Site No. 8402

    Parkville

  • Site No. 8415

    Perth

  • Site No. 8413

    Sydney

Other trials in Australia

France13 sites

  • Site No. 9013

    Bondy

  • Site No. 9005

    Bordeaux

  • Site No. 9003

    Créteil

  • Site No. 9006

    Lille

  • Site 9012

    Montpellier

  • Site No. 9008

    Nantes

  • Site No. 9010

    Nice

  • Site No. 9007

    Paris

  • Site No. 9014

    Paris

  • Site No. 9011

    Rennes

  • Site No. 9001

    Strasbourg

  • Site No. 9002

    Toulouse

  • Site No. 9009

    Vandœuvre-lès-Nancy

Other trials in France

Germany11 sites

  • Site No. 9111

    Aachen

  • Site No. 9113

    Bonn

  • Site No. 9109

    Dresden

  • Site No. 9108

    Frankfurt am Main

  • Site No. 9106

    Hamburg

  • Site No 9105

    Hannover

  • Site No. 9112

    Heidelberg

  • Site No. 9101

    Mainz

  • Site No. 9102

    München

  • Site No. 9104

    Tübingen

  • Site No. 9110

    Ulm

Other trials in Germany

Israel6 sites

  • Site No. 9707

    Afula

  • Site 9704

    Haifa

  • Site No. 9702

    Haifa

  • Site No. 9705

    Jerusalem

  • Site No. 9703

    Ramat Gan

  • Site No. 9706

    Tel Aviv

Other trials in Israel

Taiwan6 sites

  • Site No. 8305

    Kaohsiung City

  • Site No. 8307

    Linkou District

  • Site No. 8306

    Taichung

  • Site No. 8302

    Tainan

  • Site No. 8301

    Taipei

  • Site No. 8303

    Taipei

Other trials in Taiwan

Thailand6 sites

  • Site No. 8502

    Bangkok

  • Site No. 8505

    Bangkok

  • Site No. 8503

    Chiang Mai

  • Site No. 8507

    Hat Yai

  • Site No. 8501

    Khon Kaen

  • Site No. 8506

    Phitsanulok

Other trials in Thailand

United Kingdom6 sites

  • Site No. 9501

    Birmingham

  • Site No. 9505

    Guildford

  • Site No. 9503

    Leeds

  • Site No. 9502

    London

  • Site No. 9504

    London

  • Site No. 9506

    London

Other trials in United Kingdom

Portugal5 sites

  • Site No. 9404

    Coimbra

  • Site No. 9405

    Coimbra

  • Site No. 9403

    Lisbon

  • Site No. 9401

    Porto

  • Site No. 9402

    Porto

Other trials in Portugal

Italy4 sites

  • Site No.9205

    Modena

  • Site No. 9204

    Naples

  • Site No. 9201

    Palermo

  • Site No. 9203

    Parma

Other trials in Italy

Canada3 sites

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

  • Juravinski Cancer Centre

    Hamilton, Ontario, L8V 1C3

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

Singapore3 sites

  • Site 8702

    Singapore

  • Site 8703

    Singapore

  • Site No. 8701

    Singapore

Other trials in Singapore

New Zealand2 sites

  • Auckland City Hospital

    Auckland, New Zealand, 1142

  • Site No. 8902

    Christchurch

Other trials in New Zealand

Hong Kong1 site

  • Site No. 8601

    Hong Kong

Other trials in Hong Kong

About this study

Official title: A Phase 3 Randomized, Open-Label Study Comparing Pexa Vec (Vaccinia GM CSF / Thymidine Kinase-Deactivated Virus) Followed by Sorafenib Versus Sorafenib in Patients With Advanced Hepatocellular Carcinoma (HCC) Without Prior Systemic Therapy

This is a randomized Phase 3 study to determine whether treatment with vaccinia virus based immunotherapy (Pexa-Vec) followed by sorafenib increases survival compared to treatment with sorafenib in patients with advanced hepatocellular carcinoma who have not received prior systemic therapy.

Read the detailed description

This is a multi-center, randomized, open-label, Phase 3 study comparing Pexa Vec followed by sorafenib versus sorafenib in patients with advanced HCC without prior systemic therapy.

A total of 459 patients were randomly assigned to 2 treatment arms- 234 patients in the Pexa-Vec followed by sorafenib treatment group and 225 patients in the sorafenib only treatment group.

Being tested
Pexastimogene Devacirepvec (Pexa Vec), Sorafenib
Keywords
Hepatocellular Carcinoma (HCC), Pexastimogene Devacirepvec (Pexa-Vec), Sorafenib, GM-CSF therapy, Thymidine Kinase-Deactivated Vaccinia Virus, Oncology, Recombinant Vaccinia Virus, Oncolytic Virus Therapy, Oncolytic virotherapy
Medical subject headings
Carcinoma, Hepatocellular, Neoplasms, Vaccinia

What participants receive

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

  • Pexastimogene Devacirepvec (Pexa Vec)Biological

    Also called JX-594

    Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells.

  • SorafenibDrug

    Also called Nexavar

    Sorafenib belongs to the pharmacotherapeutic group of antineoplastic agents, protein kinase inhibitors, ATC code: L01XE05.

    Sorafenib is a multi-kinase inhibitor which has demonstrated both anti-proliferative and anti-angiogenic properties in vitro and in vivo.

    Sorafenib is approved for the treatment of advanced HCC and is the Standard Of Care for this disease.

Study groups in NCT02562755
Study groupRoleWhat they receive
Pexa-Vec followed by SorafenibExperimentalPexa-Vec (pexastimogene devacirepvec) will be administered as 3 bi-weekly intratumoral (IT) injections of 1e9 pfu at day 1 and weeks 2 and 4, followed by sorafenib at Week 6.
Receives: Biological: Pexastimogene Devacirepvec (Pexa Vec); Drug: Sorafenib
SorafenibActive comparatorSorafenib (400 mg twice daily) begins on Day 1.
Receives: Drug: Sorafenib

What is being measured

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

  1. Overall Response Rate (ORR)

    Percentage of participants who showed overall response during their participation in the study. Per Modified Response Evaluation Criteria In Solid Tumors Criteria (mRECIST) and assessed by tri-phasic contrast enhanced CT: Complete Response (CR), Disappearance of intratumoral enhancing area; Partial Response (PR), >=30% decrease in the sum of the diameters of enhancing area; Overall Response (OR) = CR + PR.

    Measured: From date of randomization to the date of first documented radiographic tumor progression up to 53 months

Timeline

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

  1. First posted29 Sep 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionJul 2020
  4. Study completionJul 2020

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
459 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02562755
Sponsor's protocol ID
JX594-HEP024
Acronym
PHOCUS
Status last verified
May 2026
First submitted
24 Sep 2015
Last updated
8 Jun 2026
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pexastimogene Devacirepvec (Pexa Vec) and Sorafenib in people with Hepatocellular Carcinoma (HCC), run by SillaJen, Inc. at 142 sites in 16 countries.

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 7 inclusion and 9 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 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 142 sites in United States, South Korea, China, Australia, France and 11 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 16 Dec 2020). 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?

Overall Response Rate (ORR) (time frame: From date of randomization to the date of first documented radiographic tumor progression up to 53 months). 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 NCT02562755.

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 8 Jun 2026.

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