Nasopharyngeal Cancinoma (NPC), Nasopharyngeal Cancer
Conditions
Keywords
tislelizumab, PD-1 antibody, short-course
Brief 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.
Interventions
DRUGtislelizumab
Neoadjuvant tislelizumab 200 mg, every 3 weeks for 3 cycles; Adjuvant tislelizumab 400 mg, every 6 weeks for 3 cycles.
neoadjuvent gemcitabine (1000 mg/m2 d1, d8) and cisplatin (80 mg/m2 d1) every 3 weeks for 3 cycles
Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation
RADIATIONintensity-modulated radiotherapy
Defnitive intensity-modulated radiotherapy (IMRT) of 6996cGy will be given in 33 fractions.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 and ≤65 years 2. Patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma according to WHO criteria. 3. Eastern Cooperative Oncology Group performance score of 0-1. 4. Tumor staged as T4N1 and T1-4N2-3 disease (AJCC 9th edition). 5. Adequate marrow function: white blood cell count \> 4 × 10⁹/L hemoglobin \>90g/L and platelet count \>100×10⁹/L 6. Adequate hepatic and renal function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN), Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×ULN, Alkaline phosphatase ≤ 2.5 ×ULN, clearance rate ≥ 60 ml/min 7. Other laboratory and clinical criteria Normal: thyroid function, serum amylase and lipase, pituitary hormone levels, inflammatory markers, cardiac enzyme tests and electrocardiogram (ECG); For patients aged \>50 years with a history of smoking, normal pulmonary function test (PFT) results are required; For patients with abnormal ECG findings or a prior history of cardiovascular disease (not meeting any
Exclusion criteria
listed in Item 8), additional assessments including myocardial function evaluation and cardiac ultrasound (echocardiography) must be performed, with results within normal limits. 8\. Patients must be informed of the investigational nature of this study and give written informed consent, and be willing and able to comply with the study schedule, including follow-up visits, treatment procedures, laboratory testing, and other protocol-related requirements. 9\. Women of childbearing potential (WOCBP) must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of study drug.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Failure-free survival (FFS) | 3 years | From date of randomization until the date of first documented locoregional recurrence, distant metastasis, or death from any cause, whichever occurred first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 3 years | From date of randomization until the date of death from any cause, whichever came first |
| Distant metastasis-free survival (DMFS) | 3 years | From date of randomization until the date of first documented distant metastasis, whichever occurred first |
| Locoregional recurrence-free survival (LRRFS) | 3 years | From date of randomization until the date of first documented locoregional recurrence, whichever occurred first |
| Adverse events (AEs) | within 5 years | Graded according to CTCAE V5.0 |
| Quality of life (QoL) | week 0, 9, 16, 28, 40 and 1 year, 2 years, 3 years, 4 years, and 5 years after randomization | 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. |
| cost-effectiveness analysis | 3 years | 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. |
Contacts
CONTACTJun Ma
CONTACTYelin Liang
Outcome results
None listed