This study aims to explore a new, more effective and tolerable treatment regimen for patients with advanced recurrent/metastatic nasopharyngeal carcinoma. Specifically, we plan to conduct a phase III randomized controlled clinical trial based on the standard treatment of "GP + PD-1 mAb", replacing cisplatin with apatinib to achieve "platinum-free" therapy and reduce toxicity. In addition, we will investigate the efficacy of using apatinib in combination with PD-1 mAb compared to PD-1 mAb monotherapy to further improve treatment outcomes. The ultimate goal is to provide a new and reliable treatment modality for patients with advanced recurrent/metastatic nasopharyngeal carcinoma and guide clinical practice.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
244
200mg, D1, Q3W, iv drip.
1000mg/m2, Day 1 and Day 8, Q3W, iv drip, maximum 6 cycles.
80 mg/m2, D1, Q3W, iv drip, maximum 6 cycles.
250mg, PO, QD
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGProgression-free survival
the time from treatment initiation to disease progression or death from any cause.
Time frame: 2 years
Overall survival
the survival time until death from any cause
Time frame: 2 years
Objective response rate
the proportion of patients with complete response (CR) or partial response (PR) according to RECIST v1.1
Time frame: 2 years
Disease control rate
the proportion of patients who achieved CR, PR, or stable disease
Time frame: 2 years
Duration of response
the time from the first evidence of response to disease progression or death
Time frame: 2 years
Safety evaluation
incidence of adverse events
Time frame: 2 years
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