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

被引:27
作者
Ben Khaled, Najib [1 ]
Seidensticker, Max [2 ]
Ricke, Jens [2 ]
Mayerle, Julia [1 ]
Oehrle, Bettina [1 ]
Roessler, Daniel [1 ]
Teupser, Daniel [3 ]
Ehmer, Ursula [4 ]
Bitzer, Michael [5 ,6 ]
Waldschmidt, Dirk [7 ]
Fuchs, Martin [8 ]
Reuken, Philipp A. [9 ]
Lange, Christian M. [1 ,10 ]
Wege, Henning [11 ]
Kandulski, Arne [12 ]
Dechene, Alexander [13 ]
Venerito, Marino [14 ]
Berres, Marie-Luise [15 ]
Luedde, Tom [16 ]
Kubisch, Ilja [17 ]
Reiter, Florian P. [18 ]
De Toni, Enrico N. [1 ]
机构
[1] Ludwig Maximilians Univ Munchen, Dept Med 2, Univ Hosp, D-81377 Munich, Germany
[2] Ludwig Maximilians Univ Munchen, Dept Radiol, Univ Hosp, D-81377 Munich, Germany
[3] Ludwig Maximilians Univ Munchen, Inst Lab Med, Univ Hosp, D-81377 Munich, Germany
[4] Tech Univ Munich, Klinikum Rechts Isar, Internal Med 2, D-81675 Munich, Germany
[5] Eberhard Karls Univ Tubingen, Dept Internal Med 1, D-72016 Tubingen, Germany
[6] Eberhard Karls Univ Tubingen, Ctr Personalized Med, D-72016 Tubingen, Germany
[7] Univ Hosp Cologne, Dept Gastroenterol, D-50937 Cologne, Germany
[8] Munich Hosp Bogenhausen, Dept Gastroenterol Hepatol & GI Oncol, D-81925 Munich, Germany
[9] Jena Univ Hosp, Dept Internal Med 4, D-07743 Jena, Germany
[10] Univ Hosp Essen, Dept Gastroenterol & Hepatol, D-45147 Essen, Germany
[11] Med Ctr Esslingen, Canc Ctr Esslingen, D-73730 Esslingen, Germany
[12] Univ Hosp Regensburg, Dept Gastroenterol, D-93053 Regensburg, Germany
[13] Gen Hosp Nuremberg, Dept Gastroenterol Hepatol & Endocrinol, D-90419 Nurnberg, Germany
[14] Otto von Guericke Univ Hosp, Dept Gastroenterol Hepatol & Infect Dis, D-39120 Magdeburg, Germany
[15] Univ Hosp Aachen, Med Dept 3, D-52074 Aachen, Germany
[16] Univ Hosp Dusseldorf, Clin Gastroenterol Hepatol & Infect Dis, D-40225 Dusseldorf, Germany
[17] Klinikum Chemnitz gGmbH, Dept Internal Med 2, Gastroenterol Hepatol Endocrinol Metab Disorders, D-09116 Chemnitz, Germany
[18] Univ Hosp Wurzburg, Dept Med 2, Div Hepatol, D-97080 Wurzburg, Germany
关键词
atezolizumab; BCLC B; bevacizumab; hepatocellular carcinoma; immunotherapy; liver cancer; PD-L1; transarterial chemoembolization; VEGF; ENDOTHELIAL GROWTH-FACTOR; DOUBLE-BLIND; PHASE-III; ARTERIAL CHEMOEMBOLIZATION; RADIOFREQUENCY ABLATION; PLUS BEVACIZUMAB; SORAFENIB; CELL; MULTICENTER; COMBINATION;
D O I
10.2217/fon-2021-1261
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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 2 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.
引用
收藏
页码:1423 / 1435
页数:13
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