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Engineered virus takes on liver cancer when standard treatment fails

NCT ID NCT01387555

Disease control Sponsor: Jennerex Biotherapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time

Summary

This trial investigates whether JX-594 (Pexa-Vec), a virus modified to attack cancer cells and boost the immune system, combined with best supportive care, can help people with advanced liver cancer live longer. The study enrolls adults whose liver cancer has progressed or who could not tolerate the standard drug sorafenib. Participants are randomly assigned to receive either the virus therapy plus supportive care or supportive care alone, and their survival is compared.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
JX-594 (Pexa-Vec) – a modified virus designed to infect and destroy cancer cells and stimulate the immune system
What this could lead to
If successful, this could provide a new treatment option for people with advanced liver cancer who have stopped responding to standard therapy, potentially extending survival.
What could go wrong
This is a Phase 2 trial with a relatively small number of participants. The virus-based therapy may cause flu-like symptoms or other side effects, and it is not yet proven to improve survival.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

129 people

The number who actually took part.

Started

Oct 2011

Finished

Oct 2013

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

KEY Inclusion Criteria: * Diagnosis of primary HCC by tissue biopsy (histological/cytological diagnosis), or clinical diagnosis * Previously treated with sorafenib for ≥ 14 days and has discontinued sorafenib treatment at least 14 days prior to randomization due to either intolerance or radiographic progression NOTE: Sorafenib is NOT required to be the most recent treatment received for HCC * ECOG performance status 0, 1 or 2 * Child-Pugh Class A; or Child-Pugh Class B7 without clinically significant ascites * Hematocrit ≥30% or Hemoglobin ≥10 g/dL * Tumor status: Measurable viable tumor in the liver and injectable under imaging-guidance; At least one tumor in the liver that has not received prior local-regional treatment OR that has exhibited \>25% growth in viable tumor size since prior local-regional treatment. KEY Exclusion Criteria: * Received sorafenib within 14 days prior to randomization * Received systemic anti-cancer therapy other than sorafenib within 28 days of randomization * Prior treatment with JX-594 * Platelet count \< 50,000 PLT/ mm3 * Total white blood cell count \< 2,000 cells/mm3 * Prior or planned organ transplant * Known significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication * Severe or unstable cardiac disease * Viable CNS malignancy associated with clinical symptoms * Pregnant or nursing an infant * History of inflammatory skin condition (e.g., eczema requiring previous treatment, atopic dermatitis)

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Conditions

The condition(s) this trial relates to.

hepatocellular carcinoma liver cancer Liver Neoplasms oculocerebral hypopigmentation syndrome of Preus vaccinia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HCC Hepatocellular carcinoma Liver cancer

Contacts and locations

Locations

  • Asan Medical Center

    Seoul, 138-736, South Korea

  • Billings Clinic

    Billings, Montana, United States

  • CHU d'Estaing

    Clermont-Ferrand, Auvergne, 63003, France

  • California Pacific Medical Center

    San Francisco, California, United States

  • Centre Hospitalier Universitaire Hôpital Saint André

    Bordeaux, Aquitaine, 33000, France

  • Chao Family Comprehensive Cancer Center

    Orange, California, 92868, United States

  • Gabrail Cancer Center

    Canton, Ohio, United States

  • Hôpital Purpan

    Toulouse, Midi-Pyrenees, 31059, France

  • Hôpital Saint Antoine, CPP Ile de France V

    Paris, Île-de-France Region, 75571, France

  • Hôpital de la Croix Rousse

    Lyon, Auvergne-Rhône-Alpes, 69317, France

  • Hôpitaux Universitaires de Strasbourg - Hôpital Civil

    Strasbourg, Alsace, 67091, France

  • Johannes Gutenberg-Universität Mainz

    Mainz, Rhineland-Palatinate, 55131, Germany

  • Juravinski Cancer Centre

    Hamilton, Ontario, Canada

  • Klinikum Rechts der Isar der Technischen Universität München

    München, Bavaria, 81675, Germany

  • Korea University Ansan Hospital

    Ansan-si, Gyeonggi-do, 425-707, South Korea

  • Korea University Guro Hospital

    Seoul, South Korea

  • Kyungpook National University Hospital

    Daegu, South Korea

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, 30625, Germany

  • Montefiore Medical Center

    The Bronx, New York, United States

  • Moores University of California San Diego Cancer Center

    La Jolla, California, 92093, United States

  • National Cheng-Kung University Hospital

    Tainan, Taiwan

  • National Taiwan University Hospital

    Taipei, Taiwan

  • Ottawa Hopsital Research Institute

    Ottawa, Ontario, Canada

  • Pusan National University Hospital

    Pusan, South Korea

  • Pusan National University Yangsan Hospital

    Yangsan, South Korea

  • Queen Mary Hospital

    Hong Kong, Hong Kong

  • Saint Joseph's Hospital

    Paterson, New Jersey, United States

  • Samsung Medical Center

    Seoul, South Korea

  • Seoul National University Hospital

    Seoul, South Korea

  • Severance Hospital,Yonsei University Health System

    Seoul, South Korea

  • Stanford Hospital and Clinics

    Stanford, California, United States

  • Taipei Veterans General Hospital

    Taipei, Taiwan

  • The Methodist Hospital Department of Surgery

    Houston, Texas, 77030, United States

  • University Hospitals Case Medical Center

    Cleveland, Ohio, United States

  • University of Alberta

    Edmonton, Alberta, T6G 2B7, Canada

  • University of British Columbia

    Vancouver, British Columbia, Canada

  • University of Chicago Medical Center

    Chicago, Illinois, United States

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246, Germany

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