进行中(不再招募) NCT02519348

Durvalumab 或 Tremelimumab 单药治疗,或 Durvalumab 联合 Tremelimumab 或 Bevacizumab 用于晚期肝细胞癌的研究

肝癌食管癌Phase IIIII 期IV 期

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。