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.

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 weighing ≥60 kg) in combination with cisplatin 75 mg/m

SUBMITTER: Lu Z 

PROVIDER: S-EPMC9016493 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature