biostudies-literatureUnknown377Lu ZEli Lilly and Company<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<supBMJ (Clinical research ed.)e068714https://www.ebi.ac.uk/biostudies/studies/S-EPMC9016493biostudies-literatureSintilimab 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.PMC9016493Zhang GShen LWang BLu ZLin XORIENT-15 study groupZhang SWang JDahan LQiu WSun PWang SLiang JPernot SXue LShu YSun GWang XGu KXia BChen XWang YLee FCLi GLi HXu NGhiringhelli FChen PYang LXie YLi NLi WGao QYang ZLi THe WLin GXu TTougeron DGalais MPJiang DYue WGao SLiu HLiu LCao GLuo ZMao RFeng GMa ZHou XLiu TCheng YVazquez Rivera MFLiu YLiu ZDing SPazo Cid RAZheng ARen TZhao KTang YEl Hajbi FKong LPan ZTao MPan YFan YDean AZaanan ALuo HCui TPan HHuang YBorg CRivera FCang SZhang YZhang XJi YMa DLiu FZang AfalseSintilimab 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.<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<sup2022-01-01T00:00:00Z2022 Apr2026-05-31T21:00:54.295Z2025-02-19T04:21:48.194ZS-EPMC90164933544046410.1136/bmj-2021-068714