JPRN-jRCTs031230128招募中2 期
envatinib plus cisplatin hepatic arterial infusion chemotherapy for borderline resectable hepatocellular carcinoma: A Multicenter Phase II Study - LEOPARD-Neo
Ikeda Masafumi0 个研究点目标入组 24 人开始时间: 2023年6月9日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 < 80age old（—）
- 性别
- All
入选标准
- •1) Histologically or clinically confirmed hepatocellular carcinoma (except for mixed type).
- •2) Presence of vascular invasion. (Vascular invasion refers to portal vein tumor thrombosis, hepatic vein tumor thrombus, and bile duct tumor thrombus.)
- •3) Technically resectable HCC
- •4) Age >=18 years and <80 years.
- •5) No prior systemic therapy of primary lesion (Prior treatment history (Local therapy such as hepatectomy, RFA, TACE) is not a consideration.
- •6) Having measurable lesions
- •7) ECOG Performance Status 0 or 1.
- •8) 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<=105 IU/L
- •ALT Male <=210 IU/L Female <=115IU/L
- •Amylase<= 264U/L
- •KidneyCr <= 1.2 mg/dL
- •Creatinine Clearance >= 50 ml/min
- •Coagulation
- •International normalized ratio (PT-INR)<= 2.3
- •9) Child-Pugh score 5-6 points.
- •10) Controllable blood pressure by the use of antihypertensive agents with no more than three drugs
- •11) Procedural cisplatin hepatic arterial infusion chemotherapy is expected to be feasible.
- •12) Written informed consent has been obtained from the patient.
排除标准
- •1) Extrahepatic metastases.
- •2) Previously treated with lenvatinib or cisplatin for hepatocellular carcinoma.
- •3) Moderate or greater ascites or pleural effusion unresponsive to treatment.
- •4) 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.)
- •5) Hepatic encephalopathy
- •6) The following serious complications
- •Uncontrolled hypertension despite treatment (diastolic pressure exceeds 100 mmHg)
- •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
- •7) Bleeding or thrombotic disease or a history of gastrointestinal bleeding or active hemoptysis within 28 days before enrollment.
- •8) Pregnant, breastfeeding, or possibly or intentionally pregnant, or wish to raise a child.
- •9) Difficult oral intake.
- •10) HIV positive.
- •11) Complicated by active infection requiring treatment (except for hepatitis virus).
- •12) Complicated by pulmonary fibrosis or interstitial pneumonia.
- •13) 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.
- •14) The investigator judges it inappropriate to conduct the study safely.
研究者
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