进行中(不再招募) NCT03847428

评估 Durvalumab 单药或联合 Bevacizumab 在治愈性治疗后高复发风险肝细胞癌患者中的疗效与安全性

肝癌胆道癌肉瘤Phase IIII 期II 期

一项全球性研究,评估 durvalumab 联合 bevacizumab 或 durvalumab 单药在具有高复发风险的肝细胞癌患者中的疗效与安全性。

适应症:Hepatocellular Carcinoma

入组条件

纳入标准

  • Histologically or cytologically (or radiologically for patients undergoing curative ablation), newly diagnosed, confirmed HCC and successfully completed curative therapy (resection or ablation)
  • Imaging to confirm disease-free status within 28 days prior to randomization
  • ECOG 0-1 at enrolment
  • Child-Pugh score of 5 or 6
  • Adequate organ and marrow function.

排除标准

  • Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC
  • Evidence of metastasis, macrovascular invasion or co-existing malignant disease on baseline imaging
  • History of hepatic encephalopathy within 12 months prior to randomization
  • Evidence, by Investigator assessment, of varices at risk of bleeding on upper endoscopy or contrast-enhanced cross-sectional imaging
  • Patients with Vp1 to Vp4 portal vein thrombosis on baseline imaging are excluded
  • Active co-infection with HBV and HDV.
  • Receipt of prior systemic anticancer therapy for HCC
  • Those on a waiting list for liver transplantation

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。