EUCTR2017-003653-42-IT进行中（未招募）1 期
Phase II study to assess efficacy and safety of metronomic oral Idarubicin in patients with hepatocarcinoma at intermediate-advanced stage after failure or intolerance to Sorafenib and Regorafenib - Metro IDA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 47
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients with
- •- Advanced hepatocarcinoma (BCLC-C) progressed or intolerant to Sorafenib, or when Sorafenib and Regorafenib is controindicated, or
- •- intermediate hepatocarcinoma (BCLC-B) not suitable or not responsive to chemoembolization (TACE), who progressed or are intolerant to Sorafenib and Regorafenib or when Sorafenib and Regorafenib is controindicated
- •A-B7 Child-Pugh score
- •Measurable or evaluable disease according to RECIST v1.1 criteria
- •Age >/= 18.
- •ECOG PS = 0-1
- •Adequate bone marrow, liver and renal functions
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 32
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •Previous treatment with molecular target therapy with the exception of sorafenib.
- •Life expectancy < 2 months
- •clinically significant cardiovascular or cerebrovascular disease
- •clinically significant acute or chronic respiratory failure
- •History of previous tumors with DFS < 5 yrs with the exception of basocellular or spinocellular skin carcinoma, in situ carcinoma of the cervix, breast or bladder
- •grade = 1 according to CTCAE residual toxicity from previous treatment .
- •previous cumulative dose of 300 mg/m2 of doxorubicina or equivalent drug
- •patients who are candidates to second line therapy with Regorafenib
研究者
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