Overview
Hepatocellular Carcinoma Study Comparing Vaccinia Virus Based Immunotherapy Plus Sorafenib vs Sorafenib Alone
Status:
Completed
Completed
Trial end date:
2020-07-01
2020-07-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
This is a randomized Phase 3 study to determine whether treatment with vaccinia virus based immunotherapy (Pexa-Vec) followed by sorafenib increases survival compared to treatment with sorafenib in patients with advanced hepatocellular carcinoma who have not received prior systemic therapy.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
SillaJen, Inc.Treatments:
Niacinamide
Sorafenib
Criteria
Inclusion Criteria:- Histological/cytological diagnosis of primary HCC
- Advanced stage HCC (Barcelona Clinic Liver Cancer [BCLC] Stage C or B per American
Association for the Study of Liver Disease [AASLD] guidelines)
- At least one measurable viable tumor in the liver, ≥1 cm longest diameter (LD), using
a dynamic imaging technique (arterial phase of triphasic computerized tomography [CT]
scan, or dynamic contrast-enhanced magnetic resonance imaging [MRI]), and injectable
under imaging-guidance (CT and/or ultrasound)
- Child-Pugh Class A
- Performance status 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
- Adequate hematological, hepatic, and renal function:
- Additional inclusion criteria exist
Exclusion Criteria:
- Histological diagnosis of cholangiocarcinoma, hepatocholangiocarcinoma, fibrolamellar
carcinoma and hepatoblastoma
- Symptomatic cardiovascular disease, including but not limited to significant coronary
artery disease (e.g., requiring angioplasty or stenting) or congestive heart failure
within the preceding 12 months
- Current or past history of cardiovascular disease (e.g.. past history of myocardial
infarction, ischemic cardiomyopathy) unless cardiology consultation and clearance has
been obtained for study participation
- History of moderate or severe ascites, bleeding esophageal varices, hepatic
encephalopathy or pleural effusions related to liver insufficiency within 6 months of
screening
- Bulky disease patients - tumors encompassing >50% of the liver volume and / or
inferior vena cava invasion
- Known significant immunodeficiency due to underlying illness (e.g., HIV/AIDS) and/or
immune-suppressive medication including high-dose corticosteroids
- Ongoing severe inflammatory skin condition (as determined by the Investigator)
requiring medical treatment
- History of severe eczema (as determined by the Investigator) requiring medical
treatment
- Additional exclusion criteria exist