Hepatocellular carcinoma
Conditions
Sponsors
Eisai Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects must have confirmed diagnosis of unresectable HCC, 2. At least 1 measurable target lesion, 3. Subjects categorized to stage B (not applicable for transarterial chemoembolization [TACE] stage C based on Barcelona Clinic Liver Cncer (BCLC) staging system, 4. Adquate bone marrow function, 5. Adequate liver function, 6. Adquate blood coagulation function, 7. Adequately controlled blood pressure (BP) with 0 or 1 antihypertensive medications, 8. Child-Pugh score A, 9. ECOG-PS 0 or 1, 10. Survival expectation of 12 weeks or longer after starting study drug, 11. Males or females aged at least 18 years (or any age greater than 18 years as determined by country legislation) at the time of informed consent
Exclusion criteria
Exclusion criteria: 1.Imaging findings for HCC corresponding to any of the following: HCC with at least 50% liver occupation Clear invasion into the bile duct Portal vein invasion at the main portal branch (Vp4) 2.Subjects who have received any systemic chemotherapy, including sorafenib, or any systemic investigational anticancer agents, including lenvatinib, for advanced/unresectable HCC. Note: Subjects who have received local hepatic injection chemotherapy are eligible. 3.Subjects who have received any anticancer therapy (including surgery, percutaneous ethanol injection, radio frequency ablation, transarterial [chemo] embolization, hepatic intra-arterial chemotherapy, biological, immunotherapy, hormonal, or radiotherapy) or any blood enhancing treatment (including blood transfusion, blood products, or agents that stimulate blood cell production, e.g., G-CSF) within 28 days prior to randomization 4.Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib in the opinion of the investigator 5.Bleeding or thrombotic disorders or use of anticoagulants such as, warfarin or similar agents requiring therapeutic INR monitoring. (Treatment with low molecular weight heparin is allowed.) 6.Gastrointestinal bleeding event or active hemoptysis (bright red blood of at least 1/2 of teaspoon) within 28 days prior to randomization 7.Gastric or esophageal varices that require treatment 8.Meningeal carcinomatosis 9.Subjects having at least 2+ proteinuria on urine dipstick testing will undergo 24 h urine collection for quantitative assessment of proteinuria. Subjects with urine protein of at least 1 g/24 h will be ineligible. 10.Arterial-portal venous shunt or arterial-venous shunt preventing proper diagnosis of tumor 11.Any medical or other condition that in the opinion of the investigator would preclude the subject's participation in a clinical study 12.Any history of drug or alcohol dependency or abuse within the prior 2 years 13.Major surgery within 3 weeks prior to randomization or scheduled for surgery during the study 14.Subject has had a liver transplant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| safety Progression-free survival | — |
Countries
Asia except Japan, Europe, Japan, North America, Oceania
Outcome results
None listed