Modified virus injected into tumors shows promise for liver cancer
NCT ID NCT00554372
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tested a modified virus called JX-594 (Pexa-Vec) in 30 people with liver cancer that could not be surgically removed. The virus was injected directly into the liver tumors to see if it could stop the cancer from growing. Researchers measured how many patients had their disease controlled at 8 weeks and checked for side effects at two different dose levels.
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 injected directly into tumors
- What this could lead to
- If successful, this could point toward a new way to control liver cancer that cannot be removed by surgery.
- What could go wrong
- This is a small, early-phase trial with only 30 participants. The virus may not shrink tumors or could cause serious side effects.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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30 people
The number who actually took part.
- Start date
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Aug 2008
- Finished
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Feb 2013
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
Inclusion Criteria * Histological confirmation or clinical/laboratory diagnosis of primary hepatocellular carcinoma (HCC) * Cancer is not surgically resectable for cure * Child Pugh A or B * Tumor progression during or after at least one prior HCC treatment regimen (Note: If standard HCC therapies are either medically contraindicated or patient has refused those treatments, the patient may be eligible for this study) * Performance Score: KPS score of ≥ 70 * Anticipated survival of at least 16 weeks * Total bilirubin ≤ 2.5 x ULN * AST, ALT \< 5.0 x ULN * WBC \> 2,500 cells/mm3 and \< 50,000 cells/mm3 (GCSF treatment allowed) * ANC \> 1,250 cells/mm3 (GCSF treatment allowed) * Hemoglobin ≥ 9 g/dL (RBC transfusion allowed) * Platelet count ≥ 50,000 plts/mm3 * Acceptable coagulation status: INR ≤ 1.5 x ULN * Acceptable kidney function: Serum creatinine \< 2.0 mg/dL * If patients are diabetic or have a screening random glucose \> 160 mg/dL, a fasting glucose must be done and patients must be WNL or Grade 1 in order to be eligible for the study * For patients who are sexually active: able and willing to abstain from sex during treatment period and for 3 weeks following treatment, and use an acceptable method of birth control for 3 months after last injection with JX-594 * Able/willing to sign an IRB/IEC/REB-approved written consent form * Able and willing to comply with study procedures and follow-up examinations, including compliance with the "Infection Control Guidelines for Patients" (in written consent form) Exclusion Criteria: * Current, known extra-hepatic tumors that, in the investigator's medical opinion, are likely to result in significant morbidity or mortality within the next 16 weeks. * Pregnant or nursing an infant * Known infection with HIV * Clinically significant active infection or uncontrolled medical condition considered high risk for investigational new drug treatment * 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 * Liver tumors in a location that would potentially result in significant clinical adverse effects if post-treatment tumor swelling were to occur (e.g. tumors impinging on the biliary tract that could affect drainage) * Severe or unstable cardiac disease * Current, known CNS malignancy * Anti-cancer therapy (e.g. RFA, TACE, PEIT, radioembolization, chemotherapy, surgery, or an investigational drug, etc.) within 4 weeks prior to first treatment * Absolute contraindication to undergoing MRI scanning * Experienced a severe systemic reaction or side-effect as a result of a previous smallpox vaccination * 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). * Inability or unwillingness to give informed consent or comply with the procedures required in the protocol * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Billings Clinic Cancer Center
Billings, Montana, 59101, United States
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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McMaster University Medical Centre
Hamilton, Ontario, L8N 1Y3, Canada
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Moores UCSD Cancer Center
La Jolla, California, 92093, United States
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Pusan National University Hospital
Busan, South Korea
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Samsung Medical Center
Seoul, South Korea
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Shin Chon Severance Hospital / Yonsei University Medical Center
Seoul, South Korea
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The Ohio State University
Columbus, Ohio, 43210, United States
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University of Pittsburgh Medical Center - Liver Cancer Center
Pittsburgh, Pennsylvania, 15213, United States
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