研究的第一部分為劑量遞增階段,旨在確定 nivolumab 在三個隊列(未感染肝細胞癌(HCC)受試者、丙型肝炎病毒(HCV)感染 HCC 受試者及乙型肝炎病毒(HBV)感染受試者)中各個不同劑量水平的安全性。 研究的第二部分為擴展階段,旨在為三個隊列中的每一個在指定劑量下產生額外的臨床數據。
適應症:Hepatocellular Carcinoma
收案條件
納入條件
- 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
排除條件
- History of autoimmune disease
- Any prior or current clinically significant ascites
- Any history of hepatic encephalopathy
收案條件維持 ClinicalTrials.gov 原始英文登錄資料,實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源:ClinicalTrials.gov,每兩週自動更新,最後同步:2026年10月8日。