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).