Clinical trial · Interventional
A Phase 2a Study of Modified Vaccinia Virus to Treat Sorafenib-naïve Advanced Liver Cancer
A Single-Arm, Open-Label Phase 2 Study of JX 594 (Thymidine Kinase-Deactivated Vaccinia Virus Plus GM-CSF) Administered by Weekly Intravenous (IV) Infusions in Sorafenib-naïve Patients With Advanced Hepatocellular Carcinoma (HCC)
NCT01636284CI-TRIAL-00049524FLASHcompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is to determine how effectively JX-594 (Pexa-Vec) will prolong life in patients with advanced Hepatocellular Carcinoma (HCC) who have not been previously treated with sorafenib, and the safe administration of JX-594 in five weekly IV infusions.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carinoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JX-594 recombinant vaccina GM-CSF | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- JX-594 recombinant vaccina GM-CSF
- description
- JX-594 recombinant vaccina GM-CSF
- interventionNames
- Biological: JX-594 recombinant vaccina GM-CSF
Primary outcomes (1)
- measure
- Number of Participants With Radiographic Response
- timeFrame
- CT scans every 6 week from Week 6 up to 12 months
- description
- Number of Participants with Complete response \[CR\] or partial response \[PR\] per modified Response Evaluation Criteria in Solid Tumors (mRECIST) for target and non-target lesions assessed by enhanced CT scan: CR, disappearance of intratumoral enhancing area; PR, \>=30% decrease in sum of diameters of enhancing area; Radiographic Response = CR + PR
Secondary outcomes (2)
- measure
- Time to Progression (TTP)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
KEY Inclusion Criteria: * Histologic or cytologic confirmation of advanced primary hepatocellular carcinoma (HCC) * Measurable tumor (at least one tumor with ≥1 cm LD of contrast-enhancement during the arterial phase on CT scanning) * ECOG performance status 0, 1 or 2 * Child-Pugh Class A; or Child-Pugh Class B7 without clinically significant ascites * Platelet count ≥50,000 plts/mm3 * WBC count ≥2,000 cells/mm3 and ≤50,000 cells/mm3 * Hemoglobin ≥10 g/dL * Adequate liver function KEY Exclusion Criteria: * Received sorafenib as previous treatment for HCC for more than 14 days * History of severe exfoliative skin condition (e.g., eczema or atopic dermatitis requiring systemic therapy for \> 4 weeks) * Prior treatment with JX-594 * 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 * Significant bleeding event within the last 12 months.
References
Publications (0)
Data not yet available
No reference posted for this study.