A Phase 2b Study of Modified Vaccinia Virus to Treat Patients Advanced Liver Cancer Who Failed Sorafenib

Not Recruiting

Trial ID: NCT01387555


This study is to determine whether JX-594 (Pexa-Vec) plus best supportive care is more effective in improving survival than best supportive care in patients with advanced Hepatocellular Carcinoma (HCC) who have failed sorafenib.

Official Title

A Phase 2b Randomized Trial of JX-594 (Vaccinia GM-CSF / TK-deactivated Virus) Plus Best Supportive Care Versus Best Supportive Care in Patients With Advanced Hepatocellular Carcinoma Who Have Failed Sorafenib Treatment

Stanford Investigator(s)

Nishita Kothary, MD
Nishita Kothary, MD

Professor of Radiology (Interventional Radiology)

Aya Kamaya, MD
Aya Kamaya, MD

Professor of Radiology (Body Imaging)

Gloria Hwang, MD
Gloria Hwang, MD

Clinical Professor, Radiology

David Hovsepian, MD
David Hovsepian, MD

Clinical Professor, Radiology

John D. Louie, MD
John D. Louie, MD

Clinical Professor, Radiology


KEY Inclusion Criteria:

   - Diagnosis of primary HCC by tissue biopsy (histological/cytological diagnosis), or
   clinical diagnosis

   - Previously treated with sorafenib for ≥ 14 days and has discontinued sorafenib
   treatment at least 14 days prior to randomization due to either intolerance or
   radiographic progression NOTE: Sorafenib is NOT required to be the most recent
   treatment received for HCC

   - ECOG performance status 0, 1 or 2

   - Child-Pugh Class A; or Child-Pugh Class B7 without clinically significant ascites

   - Hematocrit ≥30% or Hemoglobin ≥10 g/dL

   - Tumor status: Measurable viable tumor in the liver and injectable under
   imaging-guidance; At least one tumor in the liver that has not received prior
   local-regional treatment OR that has exhibited >25% growth in viable tumor size since
   prior local-regional treatment.

KEY Exclusion Criteria:

   - Received sorafenib within 14 days prior to randomization

   - Received systemic anti-cancer therapy other than sorafenib within 28 days of

   - Prior treatment with JX-594

   - Platelet count < 50,000 PLT/ mm3

   - Total white blood cell count < 2,000 cells/mm3

   - Prior or planned organ transplant

   - Known significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or

   - Severe or unstable cardiac disease

   - Viable CNS malignancy associated with clinical symptoms

   - Pregnant or nursing an infant

   - History of inflammatory skin condition (e.g., eczema requiring previous treatment,
   atopic dermatitis)


biological: JX-594 recombinant vaccina GM-CSF

other: Best Supportive Care

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

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