EUCTR2012-002992-33-IT进行中（未招募）1 期
A Multicenter, Randomized, Open-Label, Phase 3 Trial to Compare theEfficacy and Safety of Lenvatinib (E7080) Versus Sorafenib in First-LineTreatment of Subjects With Unresectable Hepatocellular Carcinoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 954
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Confirmed diagnosis of unresectable HCC with any of the following
- •criteria: histologically or cytologically confirmed diagnosis of HCC,
- •diagnosis of HCC according to the AASLD criteria, including cirrhosis of
- •any etiology or with chronic hepatitis B or C infection criteria
- •- At least 1 measurable target lesion according to mRECIST meeting the
- •criteria set out in the protocol for the different lesions
- •-Subjects categorized to stage B or stage c based on BCLC staging
- •- Adequate bone marrow function defined as
- •o Absolute neutrophil count (ANC) = 1.5 × 10e9/L
- •o Hemoglobin (Hb) = 8.5 g/dL
- •o Platelet count = 75 × 10e9/L
- •- Adequate liver function
- •o Bilirubin = 3.0 mg/dL
- •o Aspartate aminotransferase (AST), alkaline phosphatase (ALP), and
- •alanine aminotransferase (ALT) = 5 × the upper limit of normal (ULN)
- •- Adequate blood coagulation function, defined as international
- •normalized ratio (INR) = 2.3
- •- Adequate renal function, defined as creatinine clearance > 30 mL/min
- •calculated per the Cockcroft and Gault formula
- •- Adequate pancreatic function, defined as amylase and lipase = 1.5 ×
- •- Adequately controlled blood pressure with 0 or 1 antihypertensive
- •medications and no change in antihypertensive medications within 1
- •week prior to the cycle 1/ day 1
- •- 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 at time of informed consent
- •- Females must not be lactating or pregnant at Screening or Baseline. A
- •seperate baseline assessment is required if a negative pregnancy test
- •was obtained more then 72 hours before the first dose of study drug.
- •- All females will be considered to be of childbearing potential unless
- •they are postmenopausal or have been sterilized surgically.
- •- Females of childbearing potential must not have had unprotected
- •sexual intercourse within 30 days before study entry and must agree to
- •use a highly effective method of contraception (e.g., total abstinence, an
- •intrauterine device, a double-barrier method, a contraceptive implant, an
- •oral contraceptive, or have a vasectomized partner with confirmed
- •azoospermia) throughout the entire study period and for 30 days after
- •study drug discontinuation. If currently abstinent, the subject must
- •agree to use a double barrier method as described above if she becomes
- •sexually active during the study period or for 30 days after study drug
- •discontinuation. Females who are using hormonal contraceptives must
- •have been on a stable dose of the same hormonal contraceptive product
- •for at least 4 weeks before dosing and must continue to use the same
- •contraceptive during the study and for 30 days after study drug
- •discontinuation.
- •- Male subjects must have had a successful vasectomy (confirmed
- •azoospermia) or they and their female partners must meet the criteria
- •above. No sperm donation is allowed during the study period and for 30
- •days after study drug administration
- 另有 9 项未显示
排除标准
- •- Imaging findings for HCC corresponding to any of the following: HCC
- •with greater or equal 50% liver occupation, clear invasion of the bile
- •duct, portal vein invasion at the main portal branch
- •- 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
- •- 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 4.0 (CTCAE v4.0)
- •- 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
- •- Prolongation of QTc interval to > 480 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 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
- •- Active malignancy (except for HCC or definitively treated melanoma insitu,
- •basal or squamous cell carcinoma of the skin, or carcinoma in-situ
- •of the cervix) within the past 36 months
- •- Meningeal carcinomatosis
- •- Any history of, or current, brain or subdural metastases
- •- Subjects having > 1 + proteinuria on urine dipstick testing will undergo
- •24 h urine collection for quantitative assessment of proteinuria. Subjects
- •with urine protein = 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
- •- 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 2
- •- Any subject who cannot be evaluated by either triphasic liver CT or
- •triphasic liver MRI because of allergy or other contraindication to both
- 另有 4 项未显示
研究者
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