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

Not Recruiting

Trial ID: NCT02562755

Purpose

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.

Official Title

A Phase 3 Randomized, Open-Label Study Comparing Pexa Vec (Vaccinia GM CSF / Thymidine Kinase-Deactivated Virus) Followed by Sorafenib Versus Sorafenib in Patients With Advanced Hepatocellular Carcinoma (HCC) Without Prior Systemic Therapy

Stanford Investigator(s)

Nishita Kothary, MD
Nishita Kothary, MD

Professor of Radiology (Interventional Radiology)

Bernice Kwong, MD
Bernice Kwong, MD

Clinical Professor, Dermatology

David S. Wang, MD

Clinical Associate Professor, Radiology

Daniel Sze, MD, PhD
Daniel Sze, MD, PhD

Professor of Radiology (Interventional Radiology)

Eligibility


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

Intervention(s):

biological: Pexastimogene Devacirepvec (Pexa Vec)

drug: Sorafenib

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Shawn Niknam
650-721-4080

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