Hepatocellular Carcinoma Study Comparing Vaccinia Virus Based Immunotherapy Plus Sorafenib vs Sorafenib Alone
Trial ID or NCT#
NCT02562755
Status
NOT RECRUITING
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
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes
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
Investigator(s)
David S. Wang, MD
Interventional radiologist,
Radiologist,
Minimally invasive surgeon,
Diagnostic radiologist
Clinical Associate Professor, Radiology
Bernice Kwong, MD
Dermatologist,
Dermatologic oncologist,
Cutaneous oncology specialist,
Dermato-oncology specialist,
Dermatopathologist
Clinical Professor, Dermatology
Contact us to find out if this trial is right for you.
Contact
Shawn Niknam
650-721-4080
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