NCT04039607已完成3 期
A Randomized, Multi-center, Phase 3 Study of Nivolumab in Combination With Ipilimumab Compared to Sorafenib or Lenvatinib as First-Line Treatment in Participants With Advanced Hepatocellular Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 732
- 试验地点
- 388
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The main purpose of this study is to compare the overall survival (OS) of nivolumab plus ipilimumab versus standard of care (SOC) (sorafenib or lenvatinib) in all randomized participants with advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have a diagnosis of HCC based on histological confirmation
- •Participants must have an advanced HCC
- •Participants must have at least one Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measurable previously untreated lesion
- •Child-Pugh score 5 or 6
- •Eastern Cooperative Oncology Group (ECOG) performance status(PS) 0 or 1
排除标准
- •Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- •Prior liver transplant
- •Episodes of hepatic encephalopathy (greater than or equal to [>=] Grade 2) within 12 months prior to randomization
- •Active brain metastases or leptomeningeal metastases
- •Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
Nivolumab + Ipilimumab
Experimental
干预措施: Nivolumab (Drug)
Sorafenib/lenvatinib
Active Comparator
干预措施: Sorafenib (Drug)
Nivolumab + Ipilimumab
Experimental
干预措施: Ipilimumab (Drug)
Sorafenib/lenvatinib
Active Comparator
干预措施: lenvatinib (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Up to 4 years
次要结局
- Objective Response Rate (ORR)(Up to 4 years)
- Duration of Response (DOR)(Up to 4 years)
- Time to Symptom Deterioration (TTSD)(Up to 4 years)
研究者
研究点 (388)
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