EUCTR2018-003151-38-CZ进行中（未招募）1 期
A Phase 2, Randomized, Open-label Study of Relatlimab in Combination with Nivolumab in Participants with Advanced Hepatocellular Carcinoma who are Naive to IO Therapy but Progressed on Tyrosine Kinase Inhibitors
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
- 357
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
- •- Must have a diagnosis of hepatocellular carcinoma (HCC) based on histological confirmation
- •- Must have advanced/metastatic HCC
- •- Have to be immunotherapy treatment-naive; no prior immunotherapies are permitted
- •- Must have at least one Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 measurable untreated lesion
- •- Child-Pugh score of 5 or 6
- •- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 for ECOG performance status scale
- •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 215
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 142
排除标准
- •- Known fibrolamellar HCC, sarcomatoid HCC, combined hepatocellular cholangiocarcinoma
- •- Prior organ allograft or allogeneic bone marrow transplantation
- •- No uncontrolled or significant cardiovascular disease
- •- No active known autoimmune disease
研究者
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