Hepatocellular Carcinoma Study Comparing Vaccinia Virus Based Immunotherapy Plus Sorafenib vs Sorafenib Alone
Condition: Hepatocellular Carcinoma (HCC)
MeSH terms: Vaccinia; Carcinoma; Carcinoma, Hepatocellular
Intervention: Pexastimogene Devacirepvec (Pexa Vec); Sorafenib
Intervention description: Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells.; Sorafenib belongs to the pharmacotherapeutic group of antineoplastic agents, protein kinase inhibitors, ATC code: L01XE05.
Sorafenib is a multi-kinase inhibitor which has demonstrated both anti-proliferative and anti-angiogenic properties in vitro and in vivo.
Sorafenib is approved for the treatment of advanced HCC and is the Standard Of Care for this disease.
Intervention MeSH terms: Sorafenib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 459.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatocellular Carcinoma (HCC); Pexastimogene Devacirepvec (Pexa-Vec); Sorafenib; GM-CSF therapy; Thymidine Kinase-Deactivated Vaccinia Virus; Oncology; Recombinant Vaccinia Virus; Oncolytic Virus Therapy; Oncolytic virotherapy

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.
    

Eligibility 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