The current study is a phase II multi-center single arm trial to evaluate the efficacy and safety of inductive Anti-PD-1+P-GEMOX treatment followed by radiotherapy and concurrent Anti-PD-1 antibody in early-stage high-risk extranodal NK/T cell lymphoma, nasal type
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
54
200mg iv on Day 1 of each 14-day cycle for 3 cycles in induction treatment; 200mg iv on Day 1,15, 29 during RT treatment
3000 U/m2 im on Day 2 of each 14-day cycle for 3 cycles in induction treatment
1g/m2 iv on Day 2 of each 14-day cycle for 3 cycles in induction treatment
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China
RECRUITINGComplete Response rate after 3 cycles of Anti-PD-1 antibody and P-GEMOX therapy
To evaluate the complete response (CR) rate after 3 cycles of Anti-PD-1 antibody and P-GEMOX therapy according to Lyric 2016 criteria
Time frame: At the end of Cycle 3 (each cycle is 14 days)
Progression-free survival rate at year 2 after enrollment, 2y-PFS
From enrollment to disease progression or any 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
acute toxicity
evaluated according to the CTCAE criteria
Time frame: From enrollment to 3 months after treatment
Quality of Life，QoL
evaluated according to EORTC-QLQ-HN35
Time frame: baseline, 1/3/6/12/24 months after treatment
Quality of Life，QoL
evaluated according to EORTC-QLQ-C30
Time frame: baseline, 1/3/6/12/24 months after treatment
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1g/m2 iv on Day 2 of each 14-day cycle for 3 cycles in induction treatment
Involved site radiotherapy according to the ILROG guideline with primary tumor dose of 50-56Gy 14-28 days after inductive therapy