drugset / Trial / NCT06092957
Reduced-dose RT With/Without CCT Versus Standard CCRT for High-risk LANPC Who Achieved CR Post Induction Chemotherapy
Phase 3
Recruiting
504 enrolled
Sun Yat-sen University
Affiliated Cancer Hospital & Institute of Guangzhou Medical University · collabFirst Affiliated Hospital, Sun Yat-Sen University · collabGuangdong Provincial People's Hospital · collabHunan Cancer Hospital · collabSecond Affiliated Hospital, Sun Yat-Sen University · collabThe fifth Affiliated Hospital of Guangzhou Medcial University · collabTongji Hospital · collabZhongshan People's Hospital, Guangdong, China · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This prospective trial aims to enroll patients with high-risk stage III-IVA (AJCC 8th, except T3N0) locoregionally-advanced nasopharyngeal carcinoma (LANPC). Under the condition of full course of PD-1/PD-L1 blockades, patients who achieved both radiological and biological complete response after 3 cycles of platinum-based chemotherapy plus PD-1/PD-L1 blockades will be randomized in a 1:1:1 ratio to receive reduced-dose radiotherapy (60Gy/30F) alone or reduced-dose radiotherapy plus concurrent chemotherapy or standard dose radiotherapy (70Gy/33F) with concurrent chemotherapy. To solve the urgent problem of whether patients with high-risk advanced nasopharyngeal carcinoma are suitable for downgrade treatment.
Timeline
- Start
- 2023-10-09
- Primary completion
- 2029-10-30
- Completion
- 2031-10-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 100 mg/m2 | — |
| Background | Adebrelimab | Monoclonal antibody | 1200 mg | — |
| Background | Camrelizumab | Monoclonal antibody | 200 mg | — |
| Background | Toripalimab | Monoclonal antibody | 240 mg | — |