Donafenib in Advanced Hepatocellular Carcinoma: A Randomized Phase 1B Study of Safety, Efficacy, and Pharmacokinetics
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
This phase IB study of donafenib, an oral multikinase inhibitor that targets Raf kinase and receptor tyrosine kinases, is to assess toxicity,efficacy and pharmacokinetics in patients wiht advanced hepatocellular carcinoma (HCC) .
详细描述
Eligibility Criteria:
- 18 -70 years old;
- Patients with measurable, histologically proven, inoperable HCC;
- Child-Pugh (CP) score of A;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less.
- Patients received prior systemic treatments for HCC before 4 weeks;
- Patients received operate before 3 months;
- Patients received TACE before 4 weeks;
- Life expectancy at least 3 months;
- Adequate hepatic and renal function;
- Adequate hematologic function (platelet count,≥70×109per liter;hemoglobin ≥8.5 g per deciliter);
- Prothrombin time international normalized ratio≤2; or prothrombin time ≤16 seconds;or APTT≤43s;or TT≤21s.
Exclusion Criteria:
- Patients had prior treatment with sorafenib;
- CNS involvement.
Method:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 -70 years old
- •Patients with measurable, histologically proven, inoperable HCC
- •Child-Pugh (CP) score of A
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less.
- •Patients received prior systemic treatments for HCC before 4 weeks
- •Patients received operate before 3 months
- •Patients received TACE before 4 weeks
- •Life expectancy at least 3 months
- •Adequate hepatic and renal function
- •Adequate hematologic function (platelet count,≥70×109per liter;hemoglobin ≥8.5 g per deciliter)
- •Prothrombin time international normalized ratio≤2; or prothrombin time ≤16 seconds;or APTT≤43s;or TT≤21s.
排除标准
- •Patients had prior treatment with sorafenib
- •CNS involvement.
研究组 & 干预措施
Donafenib(200mg)
Donafenib 200 mg orally twice daily,each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
干预措施: Donafenib(200mg) (Drug)
Donafenib(300mg)
Donafenib 300 mg orally twice daily,each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
干预措施: Donafenib(300mg) (Drug)
结局指标
主要结局
Adverse events
时间窗: 1 years
Patient visits are scheduled every 4 weeks to monitor safety and drug accountability. Patients were monitored for adverse events by use of the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0
次要结局
- Time to progression(TTP)(1 year)