研究的第一部分为剂量递增阶段，旨在确定 nivolumab 在三个队列（未感染肝细胞癌（HCC）受试者、丙型肝炎病毒（HCV）感染 HCC 受试者及乙型肝炎病毒（HBV）感染受试者）中各个不同剂量水平的安全性。 研究的第二部分为扩展阶段，旨在为三个队列中的每一个在指定剂量下产生额外的临床数据。
适应症：Hepatocellular Carcinoma
入组条件
纳入标准
- For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
- Subjects of 18 years or older (men and women) with histologically confirmed advanced hepatocellular carcinoma, not eligible for surgical and/or locoregional therapies; or progressive disease after surgical and /or locoregional therapies
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
- Dose Escalation Phase: Child-Pugh score of 7 points or less. Cohort 5: Child-Pugh Class B (B7-B8). For all other cohorts Child-Pugh score of 6 points or less
排除标准
- History of autoimmune disease
- Any prior or current clinically significant ascites
- Any history of hepatic encephalopathy
入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。