A Multicenter, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib (E7080) Versus Sorafenib in First-line Treatment of Participants With Unresectable Hepatocellular Carcinoma

Completed · Phase 3

Conditions studied: Hepatocellular Carcinoma (HCC)

In brief

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 participants with unresectable Hepatocellular Carcinoma (HCC).

Key facts

Study ID

NCT01761266

Run by

Eisai Limited

People needed

954

Starts

2013-03-01

Expected to finish

2021-03-10

Last updated by the study team

2022-04-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Imaging findings for HCC corresponding to any of the following:
• HCC with >=50 percent liver occupation
• Clear invasion into the bile duct
• Portal vein invasion at the main portal branch (Vp4).
• Participants who have received any systemic chemotherapy, including anti-vascular endothelial growth factor (VEGF) therapy, or any systemic investigational anticancer agents, including lenvatinib, for advanced/unresectable HCC. Note: Participants who have received local hepatic injection chemotherapy are eligible.
• Participants 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, eg, granulocyte colony-stimulating factor [G-CSF]) within 28 days prior to randomization.
• Participants who have not recovered from toxicities as a result of prior anticancer therapy, except alopecia and infertility. Recovery is defined as < Grade 2 severity per Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0).
• Significant cardiovascular impairment: history of congestive heart failure > New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or stroke within 6 months of the first dose of study drug, or cardiac arrhythmia requiring medical treatment at Screening.
• Prolongation of corrected QT interval (QTc) interval to >480 millisecond (ms)
• 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 requiring therapeutic INR monitoring, eg, warfarin or similar agents. Treatment with low molecular weight heparin and factor X inhibitors which do not require INR monitoring is permitted. Antiplatelet agents are prohibited throughout the study.
• 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 interventional treatment within 28 days prior to randomization. Prophylaxis with pharmacologic therapy (eg, nonselective beta-blocker) is permitted.
• Active malignancy (except for HCC or definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix) within the past 36 months.
• Participants whose only target lesion(s) is in bone will be excluded.
• Meningeal carcinomatosis.
• Any history of or current brain or subdural metastases.
• Participants having >1+ proteinuria on urine dipstick testing will undergo a 24-hour urine collection for quantitative assessment of proteinuria. Participants with a urine protein >=1g/24 hours will be ineligible.
• Surgical arterial-portal venous shunt or arterial-venous shunt.
• Any medical or other condition that in the opinion of the investigator would preclude the participant's participation in a clinical study.
• Known intolerance to lenvatinib or sorafenib (or any of the excipients).
• Human immunodeficiency virus (HIV) positive or active infection requiring treatment (except for hepatitis virus).
• Any history of drug or alcohol dependency or abuse within the prior 6 months.
• Any participant who cannot be evaluated by either triphasic liver computed tomography (CT) or triphasic liver Magnetic resonance imaging (MRI) because of allergy or other contraindication to both CT and MRI contrast agents.
• Major surgery within 3 weeks prior to randomization or scheduled for surgery during the study.

Where it is running

• Facility # 1 — Sacramento, California, United States
• Facility # 1 — San Francisco, California, United States
• Facility # 1 — Washington D.C., District of Columbia, United States
• Facility # 1 — Tampa, Florida, United States
• Facility # 1 — Duluth, Georgia, United States
• Facility # 1 — Lawrenceville, Georgia, United States
• Facility # 1 — Baltimore, Maryland, United States
• Facility # 1 — Detroit, Michigan, United States
• Facility # 1 — Kansas City, Missouri, United States
• Facility # 1 — St Louis, Missouri, United States
• Facility # 1 — East Orange, New Jersey, United States
• Facility # 1 — Brooklyn, New York, United States
• Facility # 1 — Lake Success, New York, United States
• Facility # 1 — New York, New York, United States
• Facility # 1 — Charlotte, North Carolina, United States
• Facility # 1 — Durham, North Carolina, United States
• Facility # 1 — Portland, Oregon, United States
• Facility # 1 — Austin, Texas, United States
• Facility # 1 — Lubbock, Texas, United States
• Facility # 1 — Seattle, Washington, United States
• Facility # 1 — Camperdown, New South Wales, Australia
• Facility # 1 — Wentworthville, New South Wales, Australia
• Facility # 1 — Woolloongabba, Queensland, Australia
• Facility # 1 — Fitzroy, Victoria, Australia
• Facility # 1 — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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