articleBMJMay 28, 2024HYBRID OA

Tislelizumab plus chemotherapy versus placebo plus chemotherapy as first line treatment for advanced gastric or gastro-oesophageal junction adenocarcinoma: RATIONALE-305 randomised, double blind, phase 3 trial

Sun Yat-sen University · Sun Yat-sen University Cancer Center · +25 more institutions

PubMed
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Abstract

Abstract Objective To evaluate the efficacy and safety of tislelizumab added to chemotherapy as first line (primary) treatment for advanced gastric or gastro-oesophageal junction adenocarcinoma compared with placebo plus chemotherapy. Design Randomised, double blind, placebo controlled, phase 3 study. Setting 146 medical centres across Asia, Europe, and North America, between 13 December 2018 and 28 February 2023. Participants 1657 patients aged ≥18 years with human epidermal growth factor receptor 2 negative locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma, regardless of programmed death-ligand 1 (PD-L1) expression status, who had not received systemic…

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235
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FWCI
86.96
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100%
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17
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Authors

32

Topics & keywords

Keywords
  • Medicine
  • Internal medicine
  • Chemotherapy
  • Placebo
  • Capecitabine
  • Oxaliplatin
  • Clinical endpoint
  • Adverse effect
UN Sustainable Development Goals
  • Good health and well-being
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