The purpose of this multi-center,single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of Sintilimab with P-GemOx (pegaspargase, gemcitabine and oxaliplatin) regimen for newly diagnosed advanced extranodal natural killer/T-cell lymphoma, nasal type (ENKTL)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
All patients enrolled in the study will accept sintilimab with P-GemOx (pegaspargase, gemcitabine and oxaliplatin) regimens their first-line therapy. Patients with CR or PR will receive sintilimab maintenance therapy
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
RECRUITINGcomplete remission (CR) rate
Time frame: 2years
overall response rate (ORR)
Time frame: 2years
overall survival (OS)
Time frame: 2years
progression survival (PFS)
Time frame: 2years
disease-free survival (DFS)
Time frame: 2years
bio-marker analysis
Correlation between programmed death-ligand 1 expression and efficacy
Time frame: 2years
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