國家衛生研究院 NHRI:Item 3990099045/10834
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    題名: ATTRACTION-05 (ONO-4538-38/BMS CA209844): A randomized, multicenter, double-blind, placebo-controlled Phase 3 study of Nivolumab (Nivo) in combination with adjuvant chemotherapy in pStage III gastric and esophagogastric junction (G/EGJ) cancer
    作者: Terashima, M;Kim, YW;Yeh, TS;Chung, HC;Chen, JS;Boku, N;Kang, YK;Chen, LT;Sasako, M
    貢獻者: National Institute of Cancer Research
    摘要: Background: Nivo, a fully human IgG4 programmed death 1 (PD-1) immune checkpoint inhibitor antibody, has demonstrated survival benefits across various tumor types. In ATTRACTION-02 (ONO-4538-12), a double-blind, placebo-controlled Phase 3 study in patients (pts) with unresectable advanced or recurrent G/EGJ cancer refractory to or intolerant of standard therapy, Nivo alone (3 mg/kg Q2W) achieved significant survival benefits (overall survival [OS] and progression free survival) vs. placebo with a manageable safety profile (Yoon-Koo Kang, et al. 2017 ASCO GI Cancers Symposium). In pStage II/III G/EGJ cancer, postoperative adjuvant chemotherapy with tegafur-gimeracil-oteracil potassium (S-1) or oxaliplatin/capecitabine (CapeOX) is indicated standard of care in Asian countries. However, the efficacy of these treatments is still unsatisfactory in pts with pStage III G/EGJ cancer, and thus a new treatment strategy is required. This multinational trial will evaluate the efficacy and safety of Nivo in combination with standard adjuvant chemotherapy in pts with pStage III G/EGJ cancer (ClinicalTrials.gov Identifier: NCT03006705). Trial design: In this study, approximately 700 pts between 20 to 80 years of age with pStage III G/EGJ cancer after D2 or more extended lymph node dissection will be randomized to receive adjuvant chemotherapy (S-1 or CapeOX by investigator’s choice) + either Nivo or placebo. Treatment with Nivo, placebo, and S-1 therapy will be continued for up to 1 year, and CapeOX therapy will be administered for up to 6 months. Pts will be followed up for 5 years at maximum until consent withdrawal or the start of post-study treatment due to disease relapse. Primary endpoint is relapse free survival (RFS) by central assessment. Secondary endpoints are RFS by site investigator assessments, 3- and 5-year RFS rates by central and site investigator assessments, OS and 3- and 5-year OS rates. Japan, Korea, Taiwan and China will participate into the trial. This study has already started patient enrollment.
    日期: 2017-09
    關聯: Annals of Oncology. 2017 Sep;28(Suppl. 5):Meeting Abstract 778TiP.
    Link to: https://doi.org/10.1093/annonc/mdx369.160
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=0923-7534&DestApp=IC2JCR
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:000411324001291
    顯示於類別:[陳立宗] 會議論文/會議摘要

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