A Multicenter, Randomized, Double-Blind, Phase 3 Study of Ramucirumab (IMC-1121B) Drug Product and Best Supportive Care (BSC) Versus Placebo and BSC as Second-Line Treatment in Patients With Hepatocellular Carcinoma Following First-Line Therapy With Sorafenib (REACH)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 565
- 试验地点
- 147
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This is a Phase 3 multicenter, randomized study evaluating the safety and efficacy of ramucirumab DP plus BSC as a double-blind, placebo-controlled (placebo plus BSC) comparison.
Approximately 544 participants, at least 18 years of age, with Child-Pugh score < 7 and diagnosed with hepatocellular carcinoma will be randomized. Participants must have received sorafenib as first-line systemic treatment for hepatocellular carcinoma (HCC), and must have discontinued sorafenib prior to entering the study.
Hypothesis: This sample size will allow differentiation of the expected increase in median overall survival (OS), from 8 months in the placebo arm to 10.67 months in the ramucirumab arm.
Upon registration and completion of screening procedures, eligible participants with HCC who have disease progression during or following first-line therapy with sorafenib, or were intolerant to this agent, will be randomized to receive either ramucirumab DP or placebo.
The treatment regimen will be continued until radiographic or symptomatic progression, the development of unacceptable toxicity, noncompliance or withdrawal of consent by the participant, or investigator decision.
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
- Double (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Overall Survival (OS)
时间窗: Randomization to death from any cause (up to 37 months)
OS was defined as the time from the date of randomization to the date of death from any cause. Participants who were alive at the end of the follow-up period or were lost to follow-up were censored on the last date the participant was known to be alive.
次要结局
- Cmax of Ramucirumab, Cycle 4(1 hour following completion of Cycle 4 (14-day cycles) infusion)
- Time to Radiographic Progression (TTP)(Randomization to PD (up to 36 months))
- Change From Baseline in the Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index-8 (FHSI-8)(Baseline, Prior to infusion on Day 1 of Cycle 4, Cycle 10, and Cycle 16 (14-day cycles), and end of treatment (up to 34 months))
- Number of Participants With Treatment Emergent Positive Anti-Ramucirumab Response [Serum Anti-Ramucirumab Antibody Assessment (Immunogenicity)](Prior to treatment and 1 hour post end of infusion for Cycles 1, 4 and 7 (14-day cycles))
- Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)](Baseline to the date of first evidence of confirmed CR or PR (up to 37 months))
- Number of Participants With Adverse Events (AEs) and the Number of Participants Who Died(Baseline to study completion (up to 37 months))
- Maximum Concentration (Cmax) of Ramucirumab, Cycle 1(1 hour following the completion of Cycle 1 (14-day cycle) infusion)
- Progression-Free Survival (PFS)(Randomization to PD (up to 36 months))
- Change From Baseline in European Quality of Life Questionnaire-5 Dimensions (EQ-5D) Health State Score(Baseline, Prior to infusion on Day 1 of Cycle 4, Cycle 10, and Cycle 16 (14-day cycles), end of treatment (up to 34 months))
- Cmax of Ramucirumab, Cycle 7(1 hour following completion of Cycle 7 (14-day cycles) infusion)