JPRN-jRCT2080223705
已完成
未知
An Open-Label, Expanded Access Program With Lenvatinib for the First Line Treatment of Unresectable Hepatocellular Carcinoma
概览
- 阶段
- 未知
- 干预措施
- 未指定
- 疾病 / 适应症
- Hepatocellular Carcinoma
- 发起方
- Eisai Co., Ltd.
- 入组人数
- 30
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
未指定
相似试验
已完成
不适用
An Open-Label, Expanded Access Program with Nivolumab (ONO-4538) for cancer of unknown primary (CUP) (NivoCUP-2) Biomarker study (WJOG14620MTR)Cancer of unknown primaryJPRN-UMIN000044038West Japan Oncology Group49
进行中（未招募）
不适用
ivoCUP-2JPRN-jRCT2051200146akagawa Kazuhiko60
已完成
2 期
An Open-Label, Non-Comparative Expanded Access Study of the Raf-Kinase Inhibitor Sorafenib as a Subsequent to First-Line Therapy in Patients with Advanced Renal Cell CarcinomaAdvanced renal cell carcinomaCancer - Renal Cell CarcinomaACTRN12606000140550Austin Health75
已完成
不适用
Trastuzumab deruxtecan for subjects with HER2 mutated metastatic NSCLCJPRN-jRCT2071220096eno Shizuko30
进行中（未招募）
不适用
An Open-Label, Multi-Center, Expanded Access Program With Eribulin for the Treatment of Advanced Breast Cancer Refractory to All Other Commercially Available TherapiesEUCTR2009-017671-22-BEEisai Limited500