Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Jennerex Biotherapeutics
This was a Phase 2a, two-staged, single-arm, open-label study in sorafenib-naïve patients with advanced HCC.
Patients received 5 weekly IV infusions of Pexa-Vec and could have continued to receive IV infusions of Pexa-Vec every 3 weeks until progressive disease (PD).
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
