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
Peking University · Peking University Cancer Hospital · +30 more institutions
Abstract
Abstract Objective 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. Design Multicentre, randomised, double blind, phase 3 trial. Setting 66 sites in China and 13 sites outside of China between 14 December 2018 and 9 April 2021. Participants 659 adults (aged ≥18 years) with advanced or metastatic oesophageal squamous cell carcinoma who had not received systemic treatment. Intervention Participants were randomised 1:1 to receive sintilimab or placebo (3 mg/kg in patients weighing <60 kg or 200 mg in patients…
Citation impact
- FWCI
- 94.01
- Percentile
- 100%
- References
- 28
Authors
30- ZLZhihao LüCorresponding
Peking University, Peking University Cancer Hospital
- JWJunye Wang
Affiliated Hospital of Jining Medical University, Jining Medical University
- YSYongqian Shu
Jiangsu Province Hospital, Nanjing Medical University
- LLLianke Liu
Jiangsu Province Hospital, Nanjing Medical University
- LRLi Ren Kong
Shandong Tumor Hospital, Shandong First Medical University
Topics & keywords
- Medicine
- Chemotherapy
- Placebo
- Regimen
- Internal medicine
- Cisplatin
- Interim analysis
- Chemotherapy regimen
- Good health and well-being