jRCT2031220213进行中（未招募）不适用
A Phase 1/2, Safety Confirmation and Double-blind, Placebo-controlled, Randomized Study of Relatlimab in Combination with Nivolumab and Bevacizumab in Treatment-naive Advanced/Metastatic Hepatocellular Carcinoma
Bristol-Myers Squibb0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Participants must have histologic confirmation of advanced/metastatic HCC
- •Naive to systemic therapy for advanced/metastatic HCC
- •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
排除标准
- •Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- •Prior allogenic stem cell or solid organ transplantation
- •Prior disease history with increased risk of bleeding
- •Uncontrolled or significant cardiovascular disease
- •Participants with an active, known or suspected autoimmune disease.
结局指标
主要结局
-
DLT assessment PFS assessed by BICR
次要结局
未报告次要终点
研究者
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