演題抄録

ポスター

開催概要
開催回
第58回・2020年・京都
 

A global study to evaluate TACE in combination with durvalumab (D) ± bevacizumab (B) in patients (pts) with locoregional HCC (EMERALD-1)

演題番号 : P-524

[筆頭演者]
Masatoshi Kudo:1 
[共同演者]
Bruno Sangro:2、Shukui Qin:3、Zhenggang Ren:4、Stephen Chan:5、Joseph Erinjeri:6、Yasuaki Arai:7、Philip He:8、Shethah Morgan:8、Gordon Cohen:8、Riccardo Lencioni:9

1:Kindai University, Osaka、2:Liver Unit,Clínica Universidad de Navarra and CIBEREHD, Pamplona、3:Department of Medical Oncology,PLA Cancer Center & Bayi Clinical Trial Institute、4:Zhongshan Hospital, Fudan University、5:Department of Clinical Oncology,The Chinese University of Hong Kong、6:Memorial Sloan Kettering Cancer Center、7:National Cancer Center, Tokyo、8:AstraZeneca、9:University of Pisa School of Medicine

 

Introduction
Pts with intermediate-stage hepatocellular carcinoma (HCC) are treated with locoregional therapy such as TACE; curative therapy is not always feasible and there are no standard systemic therapies. TACE achieves tumor responses, but progression and recurrence are common, often occurring within 1 year.
Early evidence shows encouraging activity and durable responses for checkpoint inhibitors (CI), such as D, for advanced HCC and combined with TACE. CIs combined with VEGF inhibitors also show promise in advanced HCC. Thus, combining D, VEGF inhibitors, and TACE warrants study in pts with locoregional HCC.
EMERALD-1 (NCT03778957) is a randomized, double-blind, PBO-controlled, multicenter Phase 3 study assessing efficacy and safety of D monotherapy given with drug-eluting bead (DEB)-TACE or conventional TACE (cTACE) followed by D±B in pts with HCC not amenable to curative therapy.

Trial Design
600 pts will be randomized 1:1:1 to Arm A (DEB-TACE or cTACE+D and following last TACE procedure, D+PBO), Arm B (DEB-TACE or cTACE+D followed by D+B), or Arm C (DEB-TACE or cTACE). Concurrent D will begin 7 or more days after initial TACE. D±B will begin 14 or more days after the last TACE procedure.
Eligible pts must have confirmed HCC not amenable to curative therapy, a Child-Pugh score class A-B7, and an ECOG PS of 0 or 1. Pts must have an upper endoscopy to evaluate varices and bleeding risk within 6 months of randomization. A tumor tissue sample is mandatory and taken either during the 1st TACE procedure or less than 3 months prior to randomization. Pts with prior systemic therapy, a history of nephrotic/nephritic syndrome, clinically significant CV disease, extrahepatic disease, or main portal vein thrombosis (Vp3/Vp4) are excluded. Pts with active (controlled) or past hepatitis B or C may be enrolled.
Primary endpoint is PFS by blinded independent radiology review (RECIST v1.1). Secondary endpoints include OS, HRQoL, and safety.

キーワード

臓器別:Liver

手法別:Immunotherapy

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