Virus injection targets liver tumors in early trial
NCT ID NCT00629759
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tested a new treatment called JX-594, a modified virus injected directly into liver tumors. The goal was to find the safest dose and see if it could shrink tumors in 14 patients with advanced liver cancer that had not responded to standard treatments. The study focused on safety and immune response, not a cure.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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14 people
The number who actually took part.
- Start date
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Jan 2006
- Finished
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Aug 2007
- 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
-
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: * Age ≥ 18 years * Patients with hepatic carcinoma (primary or metastatic) clinically or histologically confirmed to have tumors (≤10cm maximum diameter) that are progressing (refractory to standard treatment) despite regular treatment and that can be transdermally accessed by an injection needle in an imaging-guided procedure * Tumor progression despite undergoing regular treatment such as surgery, transarterial chemoembolization, chemotherapy, and radiotherapy * Performance score: Karnofsky Performance Score (KPS) ≥70 * Expected survival of at least 16 weeks * For patients who are sexually active, able and willing to use contraceptives for a three month period during and after taking JX-594 * WBC \> 3,500 cells/mm3 * ANC \> 1,500 cells/mm3 * Hemoglobin \> 10g/dL * Platelet count \> 75,000 plts/mm3 * Serum creatinine \< 1.5 mg/dL * AST, ALT \< 2.5 x ULN * Total bilirubin ≤ 2.0 mg/dL * In patients with primary HCC, Child Pugh A or B * Able/willing to sign an IRB/IEC/REB-approved written consent form * Able and willing to comply with study procedures and follow-up examinations Exclusion Criteria: * 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) * Patients with household contacts with significant immunodeficiency * History of exfoliative skin condition (e.g. severe eczema, ectopic dermatitis, or similar skin disorder) that at some stage has required systemic therapy * Severe or unstable cardiac disease * Use of adrenal cortical hormone drug or immunosuppressant within four weeks of study enrollment
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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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Dong-A University Hospital
Busan, 602-715, South Korea
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Other studies related to the condition(s) this trial covers.
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