The current study is a phase II multi-center single arm trial to evaluate the efficacy and safety of adding Anti-PD-1 antibody in an inductive and concurrent way to radiotherapy in early-stage low-risk extranodal NK/T cell lymphoma, nasal type
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
inductive Anti-PD-1 antibody + concurrent Anti-PD-1 antibody with RT
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China
RECRUITINGRate of Complete response after inductive therapy
complete resolution of disease in imaging and biopsy after inductive therapy
Time frame: 2-4 weeks after inductive anti-PD-1 antibody
Progression-free survival rate at year 2 after enrollment, 2y-PFS
From enrollment to any disease progression or death
Time frame: 2-year
Overall Survival rate at year 2/5 after enrollment，2y-/5y-OS
From enrollment to death
Time frame: 2-year, 5-year
Rate of acute toxicity (any and above grade 3)
toxicities according to CTCAE criteria
Time frame: From enrollment to 3 months after treatment
Quality of Life change, QoL
measurement basing on EORTC-QLQ-HN35 tables
Time frame: baseline, 1/3/6/12/24 months after treatment
Quality of Life change, QoL
measurement basing on EORTC-QLQ-C30 tables
Time frame: baseline, 1/3/6/12/24 months after treatment
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