|Closed||Hepatocellular Carcinoma||Phase III||
E7080-G000-304 is a multicenter, randomized, open-label, noninferiority Phase 3 study to compare the efficacy and safety of lenvatinib versus sorafenib as a first-line systemic treatment in subjects with unresectable Hepatocellular Carcinoma (HCC).
- Subjects must have confirmed diagnosis of unresectable HCC
- At least 1 measurable target lesion
- Subjects categorized to stage B (not applicable for transarterial chemoembolization [TACE]) stage C based on Barcelona Clinic Liver Cancer (BCLC) staging system
- Adequate bone marrow function
- Adequate liver function
- Adequate blood coagulation function
- Adequately controlled blood pressure (BP) with 0 or 1 antihypertensive medications
- Child-Pugh score A
- ECOG-PS 0 or 1
- Survival expectation of 12 weeks or longer after starting study drug
- 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
Other eligibility criteria may apply.
Imaging findings for HCC corresponding to any of the following:
- HCC with greater than or equal to 50% liver occupation
- Clear invasion into the bile duct
- Portal vein invasion at the main portal branch (Vp4)
- 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.
- 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., granulocyte colony-stimulating factor [G-CSF]) within 28 days prior to randomization
- Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib in the opinion of the investigator
- 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.)
- Gastrointestinal bleeding event or active hemoptysis (bright red blood of at least 0.5 teaspoon) within 28 days prior to randomization
- Gastric or esophageal varices that require treatment
- Meningeal carcinomatosis
- Subjects having >1 + proteinuria on urine dipstick testing will undergo 24 h urine collection for quantitative assessment of proteinuria. Subjects with urine protein greater than or equal to 1 g/24 h will be ineligible.
- Arterial-portal venous shunt or arterial-venous shunt preventing proper diagnosis of tumor
- Any medical or other condition that in the opinion of the investigator would preclude the subject's participation in a clinical study
- Any history of drug or alcohol dependency or abuse within the prior 2 years
- Major surgery within 3 weeks prior to randomization or scheduled for surgery during the study
- Subject has had a liver transplant
Other exclusion criteria may apply.
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
- Talk to your health care providers first before making decisions about your health care.
- Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.