進行中(不再收案) NCT07081633

Durvalumab及Tremelimumab聯合Lenvatinib作為不可切除肝細胞癌患者的第一線治療

肝癌Phase II

這是一項第二期、單臂、多中心研究,評估durvalumab及tremelimumab聯合lenvatinib在不可切除HCC參與者中的療效及安全性。

適應症:Hepatocellular Carcinoma

收案條件

納入條件

  • 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

排除條件

  • 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

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。