EUCTR2015-001663-39-ES进行中（未招募）1 期
A Study of Safety, Tolerability, and Clinical Activity of MEDI4736 and Tremelimumab Administered as Monotherapy and in Combination to Subjects with Unresectable Hepatocellular Carcinoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- MedImmune
- 入组人数
- 120
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
- •1. Male or female subjects
- •2. 18 years and older
- •3. Confirmed diagnosis of unresectable hepatocellular carcinoma with or without concomitant viral hepatits B or hepatitis C infection.
- •4. Subjects must have either: progressed on, are intolerant to, or refused treatment with sorafenib.
- •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 110
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. Prior exposure to immune-mediated therapy
- •2. Hepatic encephalopathy characterized by asterixis
- •3. Active or prior documented gastrointestinal variceal bleed
- •4. Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment
- •6. Active or prior documented autoimmune or inflammatory disease with some exceptions
- •7. Current or prior use of immunosuppressive medication within 14 days with some exceptions
研究者
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