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NOT YET RECRUITING
NCT07373990
PHASE3

Short-course Tislelizumab Combined With Chemoradiotherapy for Nasopharyngeal Carcinoma

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

418

Start Date

2026-01-15

Completion Date

2030-12-31

Last Updated

2026-01-28

Healthy Volunteers

No

Interventions

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.