JPRN-jRCT2031230144招募中2 期
[M24-147] A Phase 2, Randomized Study to Evaluate the Optimized Dose, Safety, and Efficacy of Livmoniplimab in Combination with Budigalimab for Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) Patients who Have Progressed After an Immune Checkpoint Inhibitor Containing Regimen in First-Line HCC
Yamagishi Chika0 个研究点目标入组 120 人开始时间: 2023年6月16日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Child-Pugh A classification.
- •- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
- •- Received an immune checkpoint inhibitor in first-line (1L) hepatocellular carcinoma (HCC) treatment regimen.
- •- Adequate hematologic and end-organ function.
- •- Tissue biopsy at screening.
- •- Disease that is not amenable to curative surgical and/or locoregional therapies, or progressive disease after surgical and /or locoregional therapies.
排除标准
- •- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
- •- Prior treatment with an approved tyrosine kinase inhibitor (for example sorafenib or Lenvatinib) in 1L HCC treatment regimen.
- •- History of malignancy other than hepatocellular carcinoma (HCC) within 5 years prior to screening.
- •- Hepatic encephalopathy or requirement for medications to prevent or control encephalopathy.
- •- Moderate or severe ascites requiring recurrent non-pharmacologic intervention to maintain symptomatic control.
- •- Coinfection with active HBV infection and active HCV infection.
- •- Prior history of grade 3 or higher immune-mediated adverse event or discontinuation due to immune-mediated adverse events.
- •- Prior history of recurrent grade 3 or higher interstitial lung disease/pneumonitis.
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