Clinical Research Directory

Inclusion Criteria: * Men or women, Age ≥18 years * Patients with ECOG performance status 0 or 1 * Patients with histologically confirmed diagnosis of HCC not amenable to curative surgery or local therapy * Patients who are intolerant to or who progressed on at least one line of Tyrosine Kinase Inhibitor (TKI) and/or Checkpoint inhibitor (CPI) therapy * Patients eligible to be treated with nivolumab or under treatment with nivolumab * Patients with measurable disease based on RECIST v1.1 * Patients with Child-Pugh class A liver score within 7 days of first study dose * Patients with no history of hepatic encephalopathy * Patients with no prior or current clinically significant ascites as measured by physical examination and that requires active paracentesis for control (patients with ascites only on radiographic imaging are eligible) * Patients with HBV infection must have received antiviral therapy for at least 12 weeks and HBV viral load must be documented to be \<100 IU/mL within 7 days of first study dose * Patients with no active co-infection with HBV and HCV or HBV and HDV * Patients with no active drug or alcohol abuse * Patients with adequate organ function at screening Exclusion Criteria: * Patients with tyrosine kinase inhibitor treatment within 2 weeks of first study dose * Patients with esophageal or gastric variceal bleeding within the past 6 months * Patients with portal vein invasion at the main portal (Vp4) or the inferior vena cava or cardiac involvement of HCC based on imaging * Patients with previous solid organ or hematologic transplantation * Patients with active autoimmune disease requiring systemic treatment in the past 2 years * Patients with diagnosis of immunodeficiency or receiving systemic steroid therapy or other immunosuppressive therapy within 7 days before first study dose * Patients with previous locoregional therapy or major surgery to the liver within 6 weeks before first study dose * Patients with minor surgery to liver or another site within 1 week before first study dose * Patients treated with an investigational drug 2 weeks before first study dose