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Camrelizumab Maintenance in LA-HNSCC
NCT04861467Phase 2
Key facts
- Status
- Not yet recruiting
- Start
- Jun 2021
- Primary completion
- Jul 2025
- Countries
- 1
- Sponsor
- Chinese Academy of Medical Sciences
- Modality
- Immune Checkpoint Inhibitors
- Drugs
- camrelizumab
- Conditions
- head and neck squamous cell carcinoma (HNSCC)
01
Overview
Phase 2, randomised, open-label trial of camrelizumab in head and neck squamous cell carcinoma (HNSCC) (3 arms), sponsored by Chinese Academy of Medical Sciences. Primary endpoint: Median Progression-Free Survival up to 3 years. Planned start Jun 2021; status: not yet recruiting.
02
Design
3 arms- Study design
- RandomizedOpen-label
Experimental: Camrelizumab
Camrelizumab maintenance for patients with PR/SD after CRT.
Observation
Observation for patients with PR/SD after CRT.
Exploration: Camrelizumab
Camrelizumab maintenance for patients with CR after CRT.
03
Who it enrols
Patients with stage III-IVa locally advanced HNSCC who have completed radical chemoradiation without progression. Patients with PR/SD are randomized to Camrelizumab or Observation; patients with CR are enrolled in an exploration arm.
04
Endpoints
Primary
Median Progression-Free Survival
Secondary
1 Year Progression-Free Survival Rate
Overall Survival
Objective Response Rate
Disease Control Rate
Time to Progression
Progression-Free Survival (irRECIST 1.1)
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