PD-1 Antibody Versus Best Supportive Care After Chemoradiation in Locoregionally Advanced Nasopharyngeal Carcinoma
- Sponsor
- Sun Yat-sen University
- Study ID
- NCT03427827
- Phase
- PHASE3
- Status
- Unknown
Conditions
- Nasopharyngeal Neoplasms
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- Camrelizumab — DRUGCamrelizumab is an antibody targeting PD-1 developed by Jiangsu Hengrui Medicine, China.
Study Details
This trial is aimed to investigate whether adjuvant PD-1 antibody treatment could improve survival in locoregionally advanced nasopharyngeal carcinoma compared to best supportive care.
Key Dates
- Start date
- Jul 2, 2018
- Status verified
- Apr 2024
- Primary completion
- Feb 6, 2024
- Completion
- Feb 28, 2026
Study Design
- Enrollment
- 450 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Adjuvant PD-1 antibody armPatients randomized to this arm will receive PD-1 antibody (SHR-1210), 200mg, ivdrip (\>30 minutes), d1, q3w × 12 cycles, begining at 4-6 weeks after chemoradiation
- No Intervention: Best supportive carePatients randomized to this arm will receive best supportive care after chemoradiation
Primary Outcome Measure
failure-free survival [ Time Frame: 3 years ]