Atezolizumab and bevacizumab with transarterial chemoembolization in hepatocellular carcinoma: the DEMAND trial protocol

  • Najib Ben Khaled
  • Max Seidensticker
  • Jens Ricke
  • Julia Mayerle
  • Bettina Oehrle
  • Daniel Rössler
  • Daniel Teupser
  • Ursula Ehmer
  • Michael Bitzer
  • Dirk Waldschmidt
  • Martin Fuchs
  • Philipp A Reuken
  • Christian M Lange
  • Henning Wege
  • Arne Kandulski
  • Alexander Dechêne
  • Marino Venerito
  • Marie-Luise Berres
  • Tom Luedde
  • Ilja Kubisch
  • Florian P Reiter
  • Enrico N De Toni

Abstract

The combination of the anti-PD-L1 antibody atezolizumab and the anti-VEGF bevacizumab is the first approved immunotherapeutic regimen for first-line therapy in patients with unresectable hepatocellular carcinoma (HCC), currently approved in more than 80 countries. The efficacy and tolerability of this regimen suggest that the use of atezolizumab + bevacizumab could be extended to the treatment of patients with intermediate-stage HCC in combination with transarterial chemoembolization (TACE). The authors describe the rationale and design of the DEMAND study. This investigator-initiated, multicenter, randomized phase II study is the first trial to evaluate the safety and efficacy of atezolizumab + bevacizumab prior to or in combination with TACE in patients with intermediate-stage HCC. The primary end point is the 24-month survival rate; secondary end points include objective response rate, progression-free survival, safety and quality of life. Clinical Trial Registration: NCT04224636 (ClinicalTrials.gov).

Bibliografische Daten

OriginalspracheEnglisch
ISSN1479-6694
DOIs
StatusVeröffentlicht - 04.2022
Extern publiziertJa
PubMed 35081747