JPRN-jRCT2080223264已完成2 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
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Confirmed HCC based on histopathological findings from tumor tissues. Unresectable HCC with diagnosis confirmed pathologically or with noninvasive methods
- •- Immunotherapy-naive and have either progressed on, are intolerant to, or refused treatment with sorafenib. Subjects who receive treatment with systemic therapies other than sorafenib are not eligible
- •18 Years and older (20 years and older in Japan)
排除标准
- •- Prior exposure to immune-mediated therapy
- •- Hepatic encephalopathy within past 12 months or requirement for medications to prevent or control encephalopathy
- •- GI Bleeding (eg, esophageal varices or ulcer bleeding) within 12 months
- •- Ascites requiring non-pharmacologic intervention or escalation in pharmacologic intervention to maintain symptom control, within 6 months prior to the first scheduled dose
- •- Main portal vein thrombosis(Vp4) as documented on imaging
- •- Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment
- •- Active or prior documented autoimmune or inflammatory disease with some exceptions
- •- Current or prior use of immunosuppressive medication within 14 days with some exceptions
研究者
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