NCT07373990

Short-course Tislelizumab Combined With Chemoradiotherapy for Nasopharyngeal Carcinoma

Short-course Tislelizumab Combined With Chemoradiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma: A Randomized, Controlled, Multicenter, Phase 3 Non-inferiority Clinical Trial

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 418 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This trial aim to explore whether short-course tislelizumab (3 cycles of 200 mg q3w in the induction phase and 3 cycles of 400 mg q6w in the consolidation phase) yields non-inferior event-free survival compared to long-course tislelizumab (3 cycles of 200 mg q3w in the induction phase and 5 cycles of 400 mg q6w in the consolidation phase) in patients with locoregionally advanced nasopharyngeal carcinoma.

Conditions

• Nasopharyngeal Cancinoma (NPC)
• Nasopharyngeal Cancer

Interventions

Type	Name	Description
DRUG	tislelizumab	Neoadjuvant tislelizumab 200 mg, every 3 weeks for 3 cycles; Adjuvant tislelizumab 400 mg, every 6 weeks for 3 cycles.
DRUG	tislelizumab	Neoadjuvant tislelizumab 200 mg, every 3 weeks for 3 cycles; Adjuvant tislelizumab 400 mg, every 6 weeks for 5 cycles.
DRUG	Gemcitabine + cisplatin (GP)	neoadjuvent gemcitabine (1000 mg/m2 d1, d8) and cisplatin (80 mg/m2 d1) every 3 weeks for 3 cycles
DRUG	Cisplatin (100mg/m2)	Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation
RADIATION	intensity-modulated radiotherapy	Defnitive intensity-modulated radiotherapy (IMRT) of 6996cGy will be given in 33 fractions.

Timeline

• Start date: 2026-01-15
• Primary completion: 2028-04-30
• Completion: 2030-12-31
• First posted: 2026-01-28
• Last updated: 2026-01-28