進行中(不再收案) NCT03298451

Durvalumab與tremelimumab作為晚期肝細胞癌患者第一線治療的研究

肝癌食道癌Phase IIIIII 期IV 期

這是一項隨機、開放標籤、多中心、全球性第三期研究,旨在評估durvalumab聯合tremelimumab聯合治療及durvalumab單藥治療對比sorafenib在未曾接受全身治療的不可切除HCC患者中的療效與安全性。患者須不符合局部區域治療的條件。

適應症:Hepatocellular Carcinoma

收案條件

納入條件

  • 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

排除條件

  • 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

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。