{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["377"],"submitter":["Lu Z"],"funding":["Eli Lilly and Company"],"pubmed_abstract":["<h4>Objective</h4>To evaluate sintilimab versus placebo in combination with chemotherapy (cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil) as first line treatment of unresectable locally advanced, recurrent, or metastatic oesophageal squamous cell carcinoma.<h4>Design</h4>Multicentre, randomised, double blind, phase 3 trial.<h4>Setting</h4>66 sites in China and 13 sites outside of China between 14 December 2018 and 9 April 2021.<h4>Participants</h4>659 adults (aged ≥18 years) with advanced or metastatic oesophageal squamous cell carcinoma who had not received systemic treatment.<h4>Intervention</h4>Participants were randomised 1:1 to receive sintilimab or placebo (3 mg/kg in patients weighing <60 kg or 200 mg in patients weighing ≥60 kg) in combination with cisplatin 75 mg/m<sup"],"journal":["BMJ (Clinical research ed.)"],"pagination":["e068714"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC9016493"],"repository":["biostudies-literature"],"pubmed_title":["Sintilimab versus placebo in combination with chemotherapy as first line treatment for locally advanced or metastatic oesophageal squamous cell carcinoma (ORIENT-15): multicentre, randomised, double blind, phase 3 trial."],"pmcid":["PMC9016493"],"pubmed_authors":["Zhang G","Shen L","Wang B","Lu Z","Lin X","ORIENT-15 study group","Zhang S","Wang J","Dahan L","Qiu W","Sun P","Wang S","Liang J","Pernot S","Xue L","Shu Y","Sun G","Wang X","Gu K","Xia B","Chen X","Wang Y","Lee FC","Li G","Li H","Xu N","Ghiringhelli F","Chen P","Yang L","Xie Y","Li N","Li W","Gao Q","Yang Z","Li T","He W","Lin G","Xu T","Tougeron D","Galais MP","Jiang D","Yue W","Gao S","Liu H","Liu L","Cao G","Luo Z","Mao R","Feng G","Ma Z","Hou X","Liu T","Cheng Y","Vazquez Rivera MF","Liu Y","Liu Z","Ding S","Pazo Cid RA","Zheng A","Ren T","Zhao K","Tang Y","El Hajbi F","Kong L","Pan Z","Tao M","Pan Y","Fan Y","Dean A","Zaanan A","Luo H","Cui T","Pan H","Huang Y","Borg C","Rivera F","Cang S","Zhang Y","Zhang X","Ji Y","Ma D","Liu F","Zang A"],"additional_accession":[]},"is_claimable":false,"name":"Sintilimab versus placebo in combination with chemotherapy as first line treatment for locally advanced or metastatic oesophageal squamous cell carcinoma (ORIENT-15): multicentre, randomised, double blind, phase 3 trial.","description":"<h4>Objective</h4>To evaluate sintilimab versus placebo in combination with chemotherapy (cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil) as first line treatment of unresectable locally advanced, recurrent, or metastatic oesophageal squamous cell carcinoma.<h4>Design</h4>Multicentre, randomised, double blind, phase 3 trial.<h4>Setting</h4>66 sites in China and 13 sites outside of China between 14 December 2018 and 9 April 2021.<h4>Participants</h4>659 adults (aged ≥18 years) with advanced or metastatic oesophageal squamous cell carcinoma who had not received systemic treatment.<h4>Intervention</h4>Participants were randomised 1:1 to receive sintilimab or placebo (3 mg/kg in patients weighing <60 kg or 200 mg in patients weighing ≥60 kg) in combination with cisplatin 75 mg/m<sup","dates":{"release":"2022-01-01T00:00:00Z","publication":"2022 Apr","modification":"2026-05-31T21:00:54.295Z","creation":"2025-02-19T04:21:48.194Z"},"accession":"S-EPMC9016493","cross_references":{"pubmed":["35440464"],"doi":["10.1136/bmj-2021-068714"]}}