The purpose of this study is to evaluate the efficacy and safety of Sintilimab in combination with decitabine in the treatment of Relapsed/Refractory or advanced NK/T-cell lymphoma patients
Previous study has confirmed the efficacy of anti-PD-1 antibodies (including pembrolizumab or sintilimab). However, the CR rate of PD-1 antibody monotherapy is too low. Previous studies have demonstrated that decitabine may activate the T cells and enhance the efficacy of PD-1 antibodies in Hodgkin Lymphoma. Thus, the investigators aim to evaluate the efficacy and safety of sintilimab in combination with decitabine in the treatment of NK/T cell lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
200mg d1,ivdrip, repeated every 3 weeks
10mg d1-5, ivdrip,repeated every 3 weeks
Beijing Tongren Hospital
Beijing, China
RECRUITINGcomplete response rate
evaluated by PET-CT and MRI, according to Lugano 2014 criteria
Time frame: 24 weeks ±7 days
overall response rate
evaluated by PET-CT and MRI, according to Lugano 2014 criteria
Time frame: 24 weeks ±7 days
1-year progression free survival rate
time from date of enrollment to date of disease progression, death of any reason, whichever comes first
Time frame: up to 1year after enrollment
1-year overall survival rate
time from date of enrollment to date death of any reason
Time frame: up to 1year after enrollment
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