An Open-Label, Expanded Access Program With Lenvatinib for the First Line Treatment of Unresectable Hepatocellular Carcinoma
- Conditions
- Hepatocellular Carcinoma
- Registration Number
- JPRN-jRCT2080223705
- Lead Sponsor
- Eisai Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 30
1.Subjects must have confirmed diagnosis of unresectable HCC with any of the following criteria:
Histologically or cytologically confirmed diagnosis of HCC
Clinically confirmed diagnosis of HCC according to American Association for the Study of Liver Diseases (AASLD) criteria, including cirrhosis of any etiology or with chronic hepatitis B or C infection criteria
2.Subjects categorized to stage B (not applicable for transarterial chemoembolization [TACE]) or stage C based on Barcelona Clinic Liver Cancer (BCLC) staging system
3.Adequate bone marrow function, defined as:
Absolute neutrophil count (ANC) >= 1.5 * 109/L
Hemoglobin (Hb) >= 8.5 g/dL
Platelet count >= 75 * 109/L
4.Adequate liver function, defined as:
Aspartate aminotransferase (AST), alkaline phosphatase (ALP), and alanine aminotransferase (ALT) <= 5 * the upper limit of normal (ULN)
5.Adequate blood coagulation function, defined as international normalized ratio (INR) <= 2.3
6.Adequate renal function defined as creatinine clearance > 40 mL/min calculated per the Cockcroft and Gault formula
7.Adequate pancreatic function, defined as amylase and lipase <= 1.5 * ULN
8.Adequately controlled blood pressure (BP) with up to 3 antihypertensive agents, defined as BP <= 150/90 mmHg at Screening and no change in antihypertensive therapy within 1 week prior to first dose of study drug
9.Child-Pugh score A
10.ECOG-PS 0 or 1
11.Males or females aged at least 20 years at the time of informed consent
12.Provide written informed consent
13.Willing and able to comply with all aspects of the protocol
1. Imaging findings for HCC corresponding to any of the following:
HCC with >= 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, anti-VEGF therapy, 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, eg, granulocyte colony-stimulating factor [G-CSF]) within 28 days prior to first dose of study drug
4. Subjects 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 4.03 (CTCAE v4.03).
5. Significant cardiovascular impairment: history of congestive heart failure greater than 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
6. Prolongation of QTc interval to > 480 ms
7. Gastrointestinal malabsorption or any other condition that might affect the absorption of study drug in the opinion of the investigator
8. 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.
9. Gastrointestinal bleeding event or active hemoptysis (bright red blood of at least 0.5 teaspoon) within 28 days prior to first dose of study drug
10. Gastric or esophageal varices that require interventional treatment within 28 days prior to first dose of study drug. Prophylaxis with pharmacologic therapy (eg, nonselective beta-blocker) is permitted.
11. 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 bladder or cervix) within the past 36 months.
12. Meningeal carcinomatosis
13. Any history of or current brain or subdural metastases
14. Subjects having > 1+ proteinuria on urine dipstick testing will undergo a 24-hour urine collection for quantitative assessment of proteinuria. Subjects with a urine protein >= 1 g/24 hours will be ineligible.
15. Surgical arterial-portal venous shunt or arterial-venous shunt
16. Any medical or other condition that in the opinion of the investigator would preclude the subject's participation in a clinical study
17. Known intolerance to lenvatinib (or any of the excipients)
18. Human immunodeficiency virus (HIV) positive or active infection requiring treatment (except for hepatitis virus)
19. Any history of drug or alcohol dependency or abuse within the prior 6 months
20. Major surgery within 3 weeks prior to first dose of study drug or scheduled for surgery during the study
21. Subject has had a liver transplant
22. Females who are b
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>safety
- Secondary Outcome Measures
Name Time Method other<br>-