Trial Search Results

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

This study hopes to establish the effects, good or bad, of injecting liver tumors with Pexa-Vec before treating with sorafenib compared to sorafenib treatment alone. Pexa-Vec, an investigational recombinant vaccinia virus, is expected to preferentially replicate in and kill tumor cells. Study investigators will look atPexa-Vec's effects on survival, cancer progression, response rate, quality of life, and safety in patients with hepatocellular carcinoma.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

SillaJen, Inc.

Intervention(s):

  • Biological: Pexastimogene Devacirepvec (Pexa Vec)
  • Drug: Sorafenib

Phase:

Phase 3

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

Now accepting new patients

Contact Information

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