这是一项多中心、开放标签、分层、随机研究,旨在评估 durvalumab 或 tremelimumab 单药治疗,或 durvalumab 联合 tremelimumab 或 bevacizumab 用于晚期肝细胞癌的安全性、耐受性、抗肿瘤活性、药物动力学、药效学及免疫原性。
适应症:Hepatocellular Carcinoma
入组条件
纳入标准
- Male or female participants
- years and older (Japan-20 years and older)
- Confirmed hepatocellular carcinoma (HCC) based on histopathological findings from tumor tissues. Advanced HCC with diagnosis confirmed pathologically or with noninvasive methods.
- Immunotherapy-naïve
- Have either progressed on, are intolerant to, or refused treatment with sorafenib or another approved TKI. For arm 5 only: Have not received any prior systemic therapy for HCC.
排除标准
- Prior exposure to immune-mediated therapy
- Hepatic encephalopathy within past 12 months or requirement for medications to prevent or control encephalopathy
- Gastrointestinal bleeding (eg, esophageal varices or ulcer bleeding) within 12 months
- Ascites requiring non-pharmacologic intervention (eg, paracentesis) to maintain symptomatic control, within 6 months prior to the first scheduled dose.
- Main portal vein thrombosis (Vp4) as documented on imaging
- Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment
- Active or prior documented autoimmune or inflammatory disease with some exceptions
- Current or prior use of immunosuppressive medication within 14 days with some exceptions
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。