jRCT1031260517招募中不适用
Phase II study of Lenvatinib plus cisplatin hepatic arterial infusion chemotherapy for biological borderline resectable hepatocellular carcinoma (J-LEOPARD)
未提供0 个研究点目标入组 32 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
入排标准
- 年龄范围
- 18age old over 至 80age old not（—）
- 性别
- All
入选标准
- •Histologically or clinically confirmed hepatocellular carcinoma (except for mixed type).
- •A high-risk score of >= 2 points, based on the following factors: AFP >= 12 ng/mL, tumor diameter >5 cm, number of tumors >=3, and macroscopic vascular invasion (Vp3/Vv2)
- •Technically resectable HCC (in patients with multiple lesions, RFA is acceptable for lesions <=2 cm)
- •Age >=18 years and <80 years.
- •No prior systemic therapy of primary lesion (Prior treatment history (Local therapy such as hepatectomy, RFA, TACE) is not a consideration.
- •Measurable lesions as defined by RECIST version 1.
- •ECOG Performance Status (PS) of 0 or
- •Sufficient organ functions
- •Bone marrow
- •Neutro >= 1,500 /mm3
- •Hb >= 8.5 g/dL
- •PLT >= 75,000 /mm3
- •T-Bil <= 2.0 mg/dL
- •ALB >= 2.8 g/dL
- •AST/ALT <=150 IU/L
- •Kidney Cr <= 1.2 mg/dL
- •Creatinine Clearance >= 50 ml/min
- •Coagulation
- •International normalized ratio (PT-INR) <= 2.3
- •Child-Pugh score 5-6 points.
- •Controllable blood pressure by the use of antihypertensive agents with no more than three drugs
- •Procedural cisplatin hepatic arterial infusion chemotherapy is expected to be feasible.
- •Written informed consent has been obtained from the patient.
排除标准
- •Extrahepatic metastases.
- •Previously treated with lenvatinib or cisplatin for hepatocellular carcinoma.
- •Moderate or greater ascites or pleural effusion unresponsive to treatment.
- •When the proteinuria is 2+ or more in the urinary protein qualitative test, 24-hour urine collection is carried out, and the urinary protein is recognized over 1 g/24 hour. (However, substitution by urinary protein/creatinine ratio is allowed.)
- •Hepatic encephalopathy
- •The following serious complications
- •Uncontrolled hypertension despite treatment
- •Difficult-to-control heart failure despite treatment; angina; arrhythmias
- •Poorly controlled diabetes despite treatment
- •Myocardial infarction within 6 months of onset
- •Active double cancers (synchronous double cancers, metachronous double cancers within 3 years of disease-free interval)
- •Serious psychiatric disorder
- •History of hypersensitivity to iodine-containing drugs or contrast media.
- •Serious drug allergy
- •Bleeding or thrombotic disease or a history of gastrointestinal bleeding or active hemoptysis within 28 days before enrollment.
- •Pregnant, breastfeeding, or possibly or intentionally pregnant, or wish to raise a child.
- •Difficult oral intake.
- •HIV positive.
- •Complicated by active infection requiring treatment (except for hepatitis virus).
- •Complicated by pulmonary fibrosis or interstitial pneumonia.
- •Treatment for blood conditions (including blood transfusions, blood products or hematopoietic factors products such as Granulocyte-Colony Stimulating Factor: G-CSF) in the 14 days prior to enrollment.
- •The investigator judges it inappropriate to conduct the study safely.
研究者
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