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
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…
Citation impact
- FWCI
- 86.96
- Percentile
- 100%
- References
- 17
Authors
32Topics & keywords
- Medicine
- Internal medicine
- Chemotherapy
- Placebo
- Capecitabine
- Oxaliplatin
- Clinical endpoint
- Adverse effect
- Good health and well-being
Funding
- AAmgen
- BSBristol-Myers Squibb
- ELEli Lilly and Company
- PPfizer
- AAstraZeneca
- GGlaxoSmithKline
- SSanofi
- GSGilead Sciences
- ASAmerican Society of Clinical Oncology
- CCelgene
- ABArray BioPharma
- HHandok
- RPRegeneron Pharmaceuticals
- MKMerck KGaA
- TPTaiho Pharmaceutical
- EExelixis
- JPJazz Pharmaceuticals
- ABAeglea BioTherapeutics
- CTCelldex Therapeutics
- NNovocure
- LLLes Laboratories Pierre Fabre
- COClovis Oncology
- TTTizona Therapeutics
- HHalozyme
- APAgios Pharmaceuticals
- MTMirati Therapeutics
- BBeiGene
- IIncyte
- CBCalithera Biosciences
- IBInnovent Biologics
- TTTarveda Therapeutics
- AApollomics
- YYuhan
- MModerna
- MMacroGenics
- GTG1 Therapeutics
- SSeagen
- EEisai
- APAstellas Pharma
- ESEuropean Society for Medical Oncology
- SServier
- OPOno Pharmaceutical
- IIpsen
- GGenentech
- SSamsung
- MSMerck Sharp and Dohme
- CPChugai Pharmaceutical
- ELEli Lilly Japan
- PPharmacyclics
- LOLoxo Oncology
- DSDaiichi Sankyo Europe