Evaluate Durvalumab and Tremelimumab +/- Lenvatinib in Combination With TACE in Patients With Locoregional HCC

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05301842

Patient View

This Phase III, international study assesses the efficacy and safety of combining durvalumab, tremelimumab, and TACE, with or without lenvatinib, versus TACE alone in patients with locoregional HCC. Eligible participants have no extrahepatic disease, are Child Pugh class A, have an ECOG status of 0 or 1, and measurable disease per mRECIST, with adequate organ function.

Patient Parameters

Program Overview

A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab, tremelimumab and lenvatinib therapy in patients with locoregional hepatocellular carcinoma

Description

This is a Phase III, parallel, randomized, open-label, sponsor-blinded, 3-arm, multicenter, international study assessing the efficacy and safety of durvalumab + tremelimumab + TACE with or without lenvatinib compared with TACE alone in participants with locoregional HCC not amenable to curative therapy (eg, surgical resection, transplantation, or ablation).

Eligibility Criteria

Inclusion Criteria

  • No evidence of extrahepatic disease
  • Disease not amenable to curative surgery or transplantation or curative ablation but disease amenable to TACE
  • Child Pugh score class A
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
  • Measurable disease by Modified Response Criteria in Solid Tumors (mRECIST) criteria
  • Adequate organ and marrow function

Exclusion Criteria

  • History of symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardia arrhythmia
  • History of hepatic encephalopathy
  • Major portal vein thrombosis visible on baseline imaging
  • Uncontrolled arterial hypertension
  • Co-infection with HBV and HDV

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