進行中(不再收案) NCT02519348

Durvalumab 或 Tremelimumab 單藥治療,或 Durvalumab 聯合 Tremelimumab 或 Bevacizumab 用於晚期肝細胞癌的研究

肝癌食道癌Phase IIIII 期IV 期

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。