Virus hunts liver tumors before chemo strikes
NCT ID NCT01171651
First seen Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time
Summary
This study tests a cancer-killing virus called JX-594 (Pexa-Vec) in people with advanced liver cancer that cannot be removed by surgery. Participants receive the virus through an IV and then directly into liver tumors, followed by the standard drug sorafenib. The goal is to see if this combination is safe and tolerable.
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 cancer-killing virus, followed by sorafenib tablets
- What this could lead to
- If successful, this approach could offer a new way to treat advanced liver cancer by combining a virus that targets tumors with standard therapy.
- What could go wrong
- This is a small, early-phase safety study, so it may not show clear benefit. The virus can cause flu-like symptoms and other side effects, and results may not apply to all patients.
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
-
25 people
The number who actually took part.
- Started
-
May 2009
- Finished
-
Sep 2012
- 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 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 * Performance Score: KPS score of ≥ 70 * Platelet count ≥ 50,000 plts/mm3 * Total bilirubin ≤ 2.5 x ULN * 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). Exclusion Criteria: * 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 * 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Carcinoma, hepatocellular are added.
By submitting, you agree to our Terms of use
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
-
Pusan National University Hospital
Busan, South Korea
-
Pusan National University Yangsan Hospital
Yangsan, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a simple belly press make liver cancer radiation more precise?
- A new way to read CT scans may predict which liver surgery patients will develop Life-Threatening failure
- New combo therapy aims to stop liver cancer from coming back
- Modified virus injected into tumors shows promise for liver cancer
- New hope for kids with rare liver tumors: tailored therapy trial shows promise
- New combo therapy aims to shrink untreatable liver tumors