EUCTR2012-001514-42-DE进行中（未招募）1 期
A Phase I-II Dose Escalation and Expansion Study to Investigate the Safety, Immunoregulatory Activity, Pharmacokinetics, and Preliminary Antitumor Activity of Anti-Programmed-Death-1 (PD-1) Antibody (BMS-936558) in Advanced Hepatocellular Carcinoma in Subjects with or without Chronic Viral Hepatitis - Anti-PD-1 HCC
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
- 570
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
- •-Subjects of 18 years or older (men and women) with histologically confirmed advanced hepatocellular carcinoma, not eligible for surgical and/or locoregional therapies; or progressive disease after surgical and /or locoregional therapies
- •-Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
- •-Dose Escalation Phase: Child-Pugh score of 7 points or less. For all other cohorts Child-Pugh score of 6 points or less.
- •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 342
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 228
- •-Subjects of 18 years or older (men and women) with histologically confirmed advanced hepatocellular carcinoma, not eligible for surgical and/or locoregional therapies; or progressive disease after surgical and /or locoregional therapies
- •-Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
- •-Dose Escalation Phase: Child-Pugh score of 7 points or less. For all other cohorts Child-Pugh score of 6 points or less.
- •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 342
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 228
- •-Subjects of 18 years or older (men and women) with histologically confirmed advanced hepatocellular carcinoma, not eligible for surgical and/or locoregional therapies; or progressive disease after surgical and /or locoregional therapies
- •-Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
- •-Dose Escalation Phase: Child-Pugh score of 7 points or less. For all other cohorts Child-Pugh score of 6 points or less.
- •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 342
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 228
排除标准
- •-History of autoimmune disease
- •-Any prior or current clinically significant ascites
- •-History of autoimmune disease
- •-Any prior or current clinically significant ascites
- •-History of autoimmune disease
- •-Any prior or current clinically significant ascites
研究者
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