癌研連線CancerLink
Active, not recruiting NCT07081633

Durvalumab and Tremelimumab With Lenvatinib as First-line Treatment in Patients With Unresectable Hepatocellular Carcinoma

Liver CancerPhase 2

This is a Phase II, single-arm, multicentre study, assessing the efficacy and safety of durvalumab and tremelimumab with lenvatinib in participants with unresectable HCC.

Conditions: Hepatocellular Carcinoma

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Eligibility criteria are kept as the original English records from ClinicalTrials.gov; actual eligibility is determined by the research team's formal assessment and the informed consent form. Source: ClinicalTrials.gov, updated automatically every two weeks. Last synced: 2026年10月8日.