None listed
Conditions
Interventions
Drug : 1.1.1. Screening Phase
- Begins by establishing the subject’s initial eligibility and signing of the informed consent form (ICF)
- Subject is assessed for study eligibility with the required t
400mg orally in the morning and 200mg orally in the evening about 12 hours apart or 200mg orally in the morning and 400mg orally in the evening about 12 hours apart) daily without food (at least 1 hou
Sponsors
National Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Signed written informed consent (2) Age ? 20 (3) Histological or clinical diagnosis of HCC based on the guidelines of the Korean Liver Cancer Association-National Cancer Center (4) Locally advanced unresectable or metastatic disease not amenable to curative surgical and/or locoregional therapies (5) Intolerant to or progressed on at least 1 prior systemic treatment for HCC (6) Having at least one measurable target lesion (per RECIST v1.1) - Patients who received prior local therapy (e.g., radiofrequency ablation, transarterial chemoembolization, transarterial embolization, radiation therapy etc.) are eligible provided that other target lesion(s) have not been previously treated with local therapy or the target lesion(s) within the field of local therapy have subsequently progressed in accordance with RECIST 1.1. (7) Child-Pugh class A or B7 (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 initiation of study treatment): ? Hemoglobin = 8.0 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 = 2.0 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) Fibrolamellar carcinoma or sarcomatoid carcinoma (2) Having active brain metastasis or leptomeningeal metastasis (3) Moderate to severe or intractable ascites (4) Presence of hepatic encephalopathy (5) Presence of active bacterial infection (6) Uncontrolled severe medical comorbidity (7) 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) (8) Other patients judged by the investigator or sub-investigator to be inappropriate as subjects of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS), Safety (incidence of treatment-emergent adverse events, based on CTCAE v5.0) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives: Overall survival (OS), Time to progression (TTP), Objective response rate (ORR), and Disease control rate (DCR) | — |
Countries
Korea, Republic of
Contacts
Public ContactBo Hyun Kim
National Cancer Center
Outcome results
None listed