Phase I/II Study of TSU-68 for Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Step 1(Phase I) Safety
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of Orantinib, an oral tyrosine kinase inhibitor of vascular endothelial growth factor receptor-2, platelet-derived growth factor receptor, and fibroblast growth factor receptor, in patients with advanced hepatocellular carcinoma (HCC).
详细描述
As HCC is a highly vascular tumor, a number of antiangiogenic agents have been tested for the treatment of HCC. Orantinib is an orally administered, small-molecule, multiple receptor tyrosine kinase inhibitor that targets vascular endothelial growth factor receptor-2 (VEGFR-2), platelet-derived growth factor receptor (PDGFR), and fibroblast growth factor receptor (FGFR). Phase I studies that have been conducted in Japan for patients with solid tumors recommended a dosage of 400 mg bid. As a potent antiangiogenic agent, Orantinib is also expected to be effective against HCC. However, because most HCC patients have accompanying liver cirrhosis or hepatitis, its safety must be reevaluated in the presence of liver function impairment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20-74
- •Patients who did not respond to surgery, RFA, TAE, chemotherapy, or radiotherapy
- •Chid-Pugh A or B
- •At least one measurable lesion by RECIST criteria
排除标准
- •Large amount of pleural effusion or ascites
- •Esophageal varices
- •Simultaneously active double cancer
研究组 & 干预措施
1
Orantinib
干预措施: Orantinib (TSU-68) (Drug)
结局指标
主要结局
Step 1(Phase I) Safety
时间窗: During chemotherapy
Step 2(Phase II) Response rate(RR)
时间窗: Until progression
次要结局
- Step 1(Phase I) Response rate(RR)(Until progression)
- Step 2(Phase II) Safety(During chemotherapy)