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Short-course Tislelizumab Combined With Chemoradiotherapy for Nasopharyngeal Carcinoma

NCT07373990 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 418

Last updated 2026-01-28

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-15
Primary Completion
2028-04-30
Completion
2030-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07373990 on ClinicalTrials.gov