演題抄録

ポスター

開催概要
開催回
第58回・2020年・京都
 

Durvalumab (D) with or without bevacizumab (B) as adjuvant therapy for patients (pts) with hepatocellular carcinoma (HCC) at risk of recurrence after curative therapy: EMERALD-2

演題番号 : P-525

[筆頭演者]
Jennifer Knox:1 
[共同演者]
Riccardo Lencioni:2、Ann-Lii Cheng:3、Sean Cleary:4、Peter Galle:5、Norihiro Kokudo:6、Joong-Won Park:7、Jian Zhou:8、Philip He:9、Shethah Morgan:9、Gordon Cohen:9、Jia Fan:8

1:Princess Margaret Cancer Centre,University of Toronto、2:University of Pisa School of Medicine、3:National Taiwan University、4:Mayo Clinic, Rochester、5:University Medical Center Mainz、6:National Center for Global Health and Medicine, Tokyo、7:National Cancer Center, Gyeonggi-do、8:Zhongshan Hospital,Fudan University、9:AstraZeneca

 

Introduction
Hepatic resection and ablation are SoC for pts with HCC, although these approaches are potentially curative the risk of recurrence is high. No effective adjuvant therapy with strong evidence exists and the prevention/delay of HCC recurrence after curative treatment presents a high unmet need.
Evidence suggests that adjuvant therapy, including immunotherapy such as D (anti-PD-L1 antibody), can prolong recurrence-free survival (RFS) in pts with early-stage HCC. Also, VEGF pathway inhibition may enhance activity of PD-L1 blockade in HCC pts.
EMERALD-2 (NCT03847428) is a Phase 3 randomized, double-blind placebo-controlled study evaluating efficacy and safety of D±B as adjuvant therapy in pts at high risk of recurrence after curative resection/ablation.

Methods
Approximately 888 pts will be randomized 1:1:1 to Arm A (D+B), Arm B (D+placebo [P]) or Arm C (P+P) less than 12 weeks of completion of curative hepatic resection or curative ablation (may include embolization). Stratification will be based on pathological microvascular invasion and geographic region. Eligible pts must have confirmed HCC, successfully completed curative therapy with imaging to confirm disease-free status less than 28 days prior to randomization, ECOG PS 0-1 and Child-Pugh score of 5 or 6. Pts must have an upper endoscopy (or contrast-enhanced cross-sectional imaging) performed within 6 months of randomization. A tumor tissue sample is mandatory for biomarker analysis. Exclusions include varices at risk of bleeding, prior systemic anticancer therapy for HCC; known fibrolamellar/sarcomatoid/extrahepatic, HCC or mixed cholangiocarcinoma + HCC; macrovascular invasion, or co-existing malignant disease at baseline; waiting for liver transplantation. Pts with active (controlled) or past HPV B or C may be enrolled.
The primary endpoint is RFS assessed by blinded independent central radiology review (RECIST v1.1). Secondary endpoints include 2-year RFS, time to recurrence, OS, HRQoL and safety.

キーワード

臓器別:Liver

手法別:Immunotherapy

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