None listed
Conditions
Interventions
Drug :
Nivolumab 3mg/kg IV is administered as 30-minute IV infusion every 2 weeks. External beam radiotherapy begins 7 days (? 3 days) after the first dose of nivolumab. The study drug is continued u
Sponsors
National Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with HCC meeting all of following criteria; (1) Signed written informed consent (2) Age ? 20 (3) Histological diagnosis of HCC (4) Having at least one typical enhanced measurable index lesion (in the liver) by dynamic CT or dynamic contrast-enhanced MRI (5) Presence of vascular invasion on dynamic CT or dynamic MRI ? an intraluminal filling defect adjacent to the primary tumor in portal vein, hepatic vein, and/or inferior vena cava ? an enhancement of the filling defect on arterial phase and a washout on portal/delayed phases. (6) Sorafenib naïve or sorafenib experienced (7) Child-Pugh class A (8) Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1 (9) Life expectancy of at least 16 weeks (10) 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 ? Platelet count = 50,000/µL ? Total bilirubin 2.8 g/dL ? Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 5 × upper limit of normal ? Prothrombin time in INR = 1.8 × upper limit of normal ? Serum creatinine = 1.5 mg/dL (11) 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.
Exclusion criteria
Exclusion criteria: (1) Receipt of 2 or more prior systemic therapies for advanced HCC. Additional prior systemic therapies used as adjuvant or local therapy are allowed. (2) Any type of anticancer agent (including investigational) within 2 weeks before enrollment (3) Having active brain metastasis or leptomeningeal metastasis (4) Moderate to severe or intractable ascites (5) A history or presence of hepatic encephalopathy (6) Presence of active bacterial infection (7) Untreated active chronic hepatitis B (8) History of portal hypertension with bleeding within the past 6 months (9) Prior liver transplant (10) Uncontrolled severe medical comorbidity (11) 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) (12) Current or past history of hypersensitivity to nivolumab
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS), Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS), Time to progression (TTP), Objective response rate, Disease control rate (DCR), Time to local progression (TLP) | — |
Countries
Korea, Republic of
Contacts
Public ContactHyesun Youn
National Cancer Center
Outcome results
None listed