JPRN-jRCT2080223705已完成Unknown
An Open-Label, Expanded Access Program With Lenvatinib for the First Line Treatment of Unresectable Hepatocellular Carcinoma
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 30
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
- >= 20age old 至 ot applicable（—）
- 性别
- All
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)
- •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
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
- •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
研究者
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
Unknown
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