进行中(不再招募) NCT07081633

Durvalumab及Tremelimumab联合Lenvatinib作为不可切除肝细胞癌患者的第一线治疗

肝癌Phase II

这是一项第二期、单臂、多中心研究,评估durvalumab及tremelimumab联合lenvatinib在不可切除HCC参与者中的疗效及安全性。

适应症:Hepatocellular Carcinoma

入组条件

纳入标准

  • Confirmed HCC based on histopathological findings from tumor tissues or radiologically findings.
  • Must not have received prior systemic therapy for unresectable 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.
  • At least 1 measurable lesion per RECSIT 1.1 guidelines

排除标准

  • Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) Grade ≥2 from previous anticancer therapy.
  • History of hepatic encephalopathy within past 12 months or requirement for medications to prevent or control encephalopathy.
  • Clinically meaningful ascites.
  • Patients with main portal vein thrombosis.
  • Active or prior documented GI bleeding.
  • Patient currently exhibits symptomatic or uncontrolled hypertension.
  • Patients co-infected with HBV and HCV, or co-infected with HBV and hepatitis D virus (HDV)
  • Uncontrolled intercurrent illness

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。