The purpose of this multi-center, single arm, phase Ⅱ clinical trail is to evaluate the efficacy and toxicity of sintilimab combined with R-CHOP regimen as first-line treatment for primary mediastinal large B-cell Lymphoma (PMBCL)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Sintilimab,200mg, d1, intravenous drip; Rituximab,375mg/㎡, d1,intravenous drip; Cyclophosphamide,750mg/㎡,d2,intravenous drip; Doxorubicin,50mg/㎡ (or Liposome doxorubicin ,40 mg/㎡),d2,intravenous drip; Vincristine,1.4mg/㎡, d2(Maximum dose 2mg),intravenous drip; Prednisone, 60mg/ m2 , d1-d5,oral administration.
complete remission (CR)
Time frame: 2years
overall response rate (ORR)
The proportion of patients with a PR and CR
Time frame: 2 years
overall survival (OS)
The time calculated from enrollment until death from any cause, with living patients censored at the last known survival date
Time frame: 2 years
progression survival (PFS)
The time from enrollment until tumor progression or death from any cause, whichever occurred first
Time frame: 2 years
bio-marker analysis
Correlation between programmed death-ligand 1 expression and efficacy
Time frame: 2 years
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