This study aims to explore the efficacy and safety of risk-adapted adjuvant therapy based on dynamic EBV-DNA changes and MRI in nasopharyngeal carcinoma patients.
This study aims to evaluate whether the 2-year failure-free survival of NPC patients treated with GP induction chemotherapy, IMRT and risk-adapted adjuvant therapy based on dynamic EBV-DNA changes and MRI results at the end of radiotherapy, is superior to that of a historical control cohort receiving standard treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
148
Clinical follow-up and surveillance only.
Capecitabine for medium-risk group Capecitabine: 1000 mg/m² orally twice daily on days 1-14,every 3 weeks. Treatment duration: 8 cycles
Tislelizumab and Capecitabine for high-risk group. Tislelizumab: 200 mg ivgtt on day 1, every 3 weeks and capecitabine: 1000 mg/m² orally twice daily on days 1-14,every 3 weeks. Treatment duration: 8 cycles(Maintenance of tislelizumab could be used in some high-risk patients after 8 cycles)
Fudan Universtiy Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITING2-year Failure Free Survival, 2-y FFS
calculated from the date of diagnosis of NPC to the date of tumor recurrence, progression, distant metastasis or death due to any cause,whichever comes earlier.
Time frame: 2 years
Overal Survival,OS
calculated from the date of diagnosis of NPC to the date of death from any cause
Time frame: 2 years
Locoregionally Failure Free Survival,LRFFS
calculated from the date of diagnosis of NPC to the date of locoregional failure or date of death from any cause, whichever comes earlier.
Time frame: 2 years
Distant failure free survival, DFFS
calculated from the date of diagnosis of NPC to the date of distant metastasis or date of death from any cause, whichever comes earlier.
Time frame: 2 years
Adverse effects (AE)
Time frame: during and after treatment (up to 2 years)
Objective Response Rate
Time frame: at the end of, 3 months and 6 months after IMRT
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