Concurrent Nivolumab and External Beam Radiation Therapy for Patients With Advanced HCC

Prior treatment

• Patients with HCC meeting all of following criteria;
  • Receipt of 2 or more prior systemic therapies for advanced HCC. Additional prior systemic therapies used as adjuvant or local therapy are allowed.
  • Any type of anticancer agent (including investigational) within 2 weeks before enrollment
  • Having active brain metastasis or leptomeningeal metastasis
  • Moderate to severe or intractable ascites
  • A history or presence of hepatic encephalopathy
  • Presence of active bacterial infection
  • Untreated active chronic hepatitis B
  • History of portal hypertension with bleeding within the past 6 months
  • Prior liver transplant
  • Uncontrolled severe medical comorbidity
  • Other malignant disease (a history of treated malignancy -other than HCC- is allowable if the patient's malignancy has been in complete remission, off chemotherapy and without additional surgical intervention, during the preceding two years)
  • Current or past history of hypersensitivity to nivolumab

• Patients with HCC meeting all of following criteria;
  • Signed written informed consent
  • Age \>= 20
  • Histological or clinical diagnosis of HCC based on the guidelines of the Korean Liver Cancer Association-National Cancer Center17
  • Having at least one typical enhanced measurable index lesion (in the liver) by dynamic CT or dynamic contrast-enhanced MRI
  • Presence of major vascular invasion on dynamic CT or dynamic MRI
  • ① an intraluminal filling defect adjacent to the primary tumor in portal vein, hepatic vein, and/or inferior vena cava
  • ② an enhancement of the filling defect on arterial phase and a washout on portal/delayed phases.
  • Sorafenib naïve or sorafenib experienced
  • Child-Pugh class A
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
  • Life expectancy of at least 16 weeks
  • Adequate hematologic and hepatic function (should be obtained within 14 days prior to screening:
  • Hemoglobin ≥ 9.0 g/dL
  • Absolute neutrophil count (ANC) ≥ 1,000/mm3 ③ Platelet count ≥ 50,000/μL
  • Total bilirubin \< 2.5 mg/dL
  • Serum albumin \>2.8 g/dL ⑥ Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 × upper limit of normal (ULN) ⑦ Prothrombin time in INR ≤ 1.8 × ULN ⑧ Serum creatinine ≤ 1.5 mg/dL
  • Women of childbearing potential and men must agree to use highly efficient contraception since signing of the IC form until at least 5 months (women) and 7 months (men) after the last study drug administration.