这是一项随机、开放标签、多中心、全球性第三期研究,旨在评估durvalumab联合tremelimumab联合治疗及durvalumab单药治疗对比sorafenib在未曾接受全身治疗的不可切除HCC患者中的疗效与安全性。患者须不符合局部区域治疗的条件。
适应症:Hepatocellular Carcinoma
入组条件
纳入标准
- HCC based on histopathological confirmation
- No prior systemic therapy for HCC
- Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C
- Child-Pugh Score class A
- ECOG performance status of 0 or 1 at enrollment
排除标准
- Hepatic encephalopathy within past 12 months or requirement for medication to prevent or control encephalopathy
- Clinically meaningful ascites
- Main portal vein tumor thrombosis
- Active or prior documented GI bleeding (eg, esophageal varices or ulcer bleeding) within 12 months
- HBV and HVC co-infection, or HBV and Hep D co-infection
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。