Education and Training

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

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.

Stanford is currently not accepting patients for this trial.

Intervention(s):

  • biological: Pexastimogene Devacirepvec (Pexa Vec)
  • drug: Sorafenib

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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Shawn Niknam
650-721-4080
Not Recruiting