EUCTR2015-001663-39-IT进行中（未招募）1 期
A Study of Safety, Tolerability, and Clinical Activity of Durvalumab and Tremelimumab Administered as Monotherapy, or Durvalumab in Combination with Tremelimumab or Bevacizumab in Subjects with Advanced Hepatocellular Carcinoma - NA
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
- 456
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 HCC based on histopathological findings from tumor tissues. Advanced HCC with diagnosis confirmed pathologically or with noninvasive methods.
- •4. Immunotherapy-naive and have either progressed on, are intolerant to, or refused treatment with sorafenib or another approved VEGFR TKI. Part 4 only: Must not have received prior systemic therapy for HCC.
- •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 292
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 164
排除标准
- •1. Prior exposure to immune-mediated therapy
- •2. Hepatic encephalopathy within past 12 months or requirement for medications to prevent or control encephalopathy.
- •3. GI Bleeding (eg, esophageal varices or ulcer bleeding) within 12 months.
- •4. Ascites requiring nonpharmacologic intervention to maintain symptom control, within 6 months prior to the first scheduled dose.
- •5. Main portal vein thrombosis (Vp4) as documented on imaging
- •6. Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment
- •7. Active or prior documented autoimmune or inflammatory disease with some exceptions
- •8. Current or prior use of immunosuppressive medication within 14 days of first dose of IP, with some exceptions
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