這是一項多中心、開放標籤、分層、隨機研究,旨在評估 durvalumab 或 tremelimumab 單藥治療,或 durvalumab 聯合 tremelimumab 或 bevacizumab 用於晚期肝細胞癌的安全性、耐受性、抗腫瘤活性、藥物動力學、藥效學及免疫原性。
適應症:Hepatocellular Carcinoma
收案條件
納入條件
- 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.
排除條件
- 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
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。