JPRN-jRCTs031180019已完成2 期
Phase II study of lenvatinib plus hepatic intra-arterial infusion chemotherapy with cisplatin for advanced hepatocellular carcinoma - LEOPARD trial
Ikeda Masafumi0 个研究点目标入组 36 人开始时间: 2018年9月26日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
研究概览
简要总结
The combination therapy of lenvatinib and hepatic arterial infusion chemotherapy with cisplatin yielded very favorable ORR and overall survival, and was well-tolerated in pts with advanced HCC. Further evaluation of this regimen in a phase III trial is warranted.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 80age old（—）
- 性别
- All
入选标准
- •1)Advanced hepatocellular carcinoma (HCC) confirmed histologically or by the typical findings of a hypervascular tumor on computed tomography or angiography
- •2)Not applicable for surgical resection, liver transplantation, local ablative therapy or TACE
- •3)No prior systemic chemotherapy for HCC
- •4)Age 20-79 years old
- •5)Presence of intrahepatic tumors affecting the prognosis, irrespective of the presence of extrahepatic tumors
- •6)Presence of measurable lesions
- •7)Eastern Cooperative Oncology Group Performance Status 0-1
- •8)Adequate organ functions
- •9)Child-Pugh score 5-6
- •10)Controlled hypertension with 3 or less antihypertensive drugs
- •11)Hepatic arterial infusion chemotherapy with CDDP technically feasible
- •12)Interval of 4 weeks or more from the last treatment for HCC
- •13)Life expectation of 12 weeks or over at least
- •14)Written informed consent
排除标准
- •1)Prior treatment with sorafenib, lenvatinib or cisplatin (including combined use with TACE)
- •2)Refractory moderate pleural effusion or ascites
- •3)Urinary protein excretion of 1 g or over on quantitative examination of a 24-hour urine sample, if qualitative examination for proteinuria reveals a result of 2+ or greater.
- •4)Hepatic encephalopathy
- •5)Serious complications
- •6)Hemorrhagic or thrombotic disease, or history of gastrointestinal bleeding or active hemoptysis.
- •7)Pregnant or lactating woman; woman of childbearing age unless using effective contraception
- •8)Oral intake impossible
- •9)Brain or meningeal metastasis
- •10)Active infection, excluding hepatitis viral infection
- •11)HIV-positive
- •12)Pulmonary fibrosis or interstitial pneumonitis
- •13)History of blood transfusion or intake of blood-forming medicines, such as G-CSF, within 14 days prior to enrollment
- •14)Unsatisfactory general condition for participation in the study as judged by the primary physician
研究者
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