264
Participants
Start Date
November 28, 2019
Primary Completion Date
January 31, 2025
Study Completion Date
January 31, 2025
Neoadjuvant therapy
The neoadjuvant therapy before radiotherapy comprised of Docetaxel 60 mg/m2 for 1 hour + Cisplatin 75 mg/m2+Nivolumab 360 mg, once every 3 weeks (Q3W), for a total of 2 cycles.
Chemotherapy concurrent with radiotherapy
Docetaxel 25 mg/m2 for 1 hour +Cisplatin 25 mg/m2, once a week (QW)
Radiotherapy
Hypofractionated radiation technique was used to deliver a definitive radiation dose
Nivolumab
Nivolumab consolidation (360 mg) via iv infusion once every 3 weeks (Q3W)±3 days after the neoadjuvant therapy and concurrent chemo-radiotherapy. Administration of nivolumab will commence on Day 1 following randomisation to Nivolumab after confirmation of eligibility and will continue on a Q3W schedule for a maximum duration of 12 months.
Observation
Observation after the neoadjuvant therapy and concurrent chemo-radiotherapy.
Sun yat-sen university cancer center, Guangzhou
The first affliated hospital of Guangzhou Medical University, Guangzhou
The First People's Hospital of Foshan, Foshan
Sun Yat-sen University
OTHER