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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
418
Neoadjuvant tislelizumab 200 mg, every 3 weeks for 3 cycles; Adjuvant tislelizumab 400 mg, every 6 weeks for 3 cycles.
Neoadjuvant tislelizumab 200 mg, every 3 weeks for 3 cycles; Adjuvant tislelizumab 400 mg, every 6 weeks for 5 cycles.
neoadjuvent gemcitabine (1000 mg/m2 d1, d8) and cisplatin (80 mg/m2 d1) every 3 weeks for 3 cycles
Failure-free survival (FFS)
From date of randomization until the date of first documented locoregional recurrence, distant metastasis, or death from any cause, whichever occurred first.
Time frame: 3 years
Overall survival (OS)
From date of randomization until the date of death from any cause, whichever came first
Time frame: 3 years
Distant metastasis-free survival (DMFS)
From date of randomization until the date of first documented distant metastasis, whichever occurred first
Time frame: 3 years
Locoregional recurrence-free survival (LRRFS)
From date of randomization until the date of first documented locoregional recurrence, whichever occurred first
Time frame: 3 years
Adverse events (AEs)
Graded according to CTCAE V5.0
Time frame: within 5 years
Quality of life (QoL)
The EORTC QoL questionnaire-C30 (EORTC QLQ-C30)version 3.0 will be used.The change of QoL from randomization to 9 weeks (at the end of neoadjuvant treatment), 16 weeks (at the end of radiotherapy), 28 weeks (at the 3nd cycle of adjuvant tislelizumab treatment), 40 (at the 5nd cycle of adjuvant tislelizumab treatment, if available), 1 year, 2 years, 3 years, 4 years, and 5 years after randomization. This questionnaire comprises 30 questions, 24 aggregated into nine multi-question scales: five functioning scales (e.g., physical), three symptom scales (e.g., fatigue), and one global health status scale. The remaining six single-question (e.g., dyspnoea) scales assess symptoms. These 15 scales will be scored according to the official Scoring Manual of EORTC QLQ-C30.
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Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation
Defnitive intensity-modulated radiotherapy (IMRT) of 6996cGy will be given in 33 fractions.
Time frame: week 0, 9, 16, 28, 40 and 1 year, 2 years, 3 years, 4 years, and 5 years after randomization
cost-effectiveness analysis
Cost-effectiveness will be evaluated as the incremental cost per clinical outcome achieved (e.g., cost per quality-adjusted life year gained or cost per event avoided) when comparing the intervention and control groups.
Time frame: 3 years