Hepatocellular Carcinoma Study Comparing Vaccinia Virus Based Immunotherapy Plus Sorafenib vs Sorafenib Alone

Completed · Phase 3

Conditions studied: Hepatocellular Carcinoma (HCC)

In brief

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.

Key facts

Study ID

NCT02562755

Run by

SillaJen, Inc.

People needed

459

Starts

2015-10-01

Expected to finish

2020-07-01

Last updated by the study team

2026-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic Arizona — Scottsdale, Arizona, United States
• UC Irvine Medical Center — Orange, California, United States
• Stanford University School of Medicine — Palo Alto, California, United States
• University of Florida Shands Hospital — Gainesville, Florida, United States
• University of Chicago — Chicago, Illinois, United States
• University of Kansas Cancer Center — Kansas City, Kansas, United States
• University of Louisville — Louisville, Kentucky, United States
• Tulane University Health Sciences Center — New Orleans, Louisiana, United States
• Mercy Medical Center, Inc. — Baltimore, Maryland, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Kansas City Research Institute — Kansas City, Missouri, United States
• Saint Louis University — St Louis, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Billings Clinic — Billings, Montana, United States
• Morristown Medical Center — Morristown, New Jersey, United States
• St. Joseph's Hospital — Paterson, New Jersey, United States
• Ohio State University — Columbus, Ohio, United States
• Hospital of The University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• University of Tennessee Medical Center — Knoxville, Tennessee, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Benaroya Research Institute at Virginia Mason Hospital — Seattle, Washington, United States
• Site No. 8409 — Adelaide, Australia
• Site No. 8412 — Adelaide, Australia
• University of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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