The purpose of this study is to evaluate the efficacy and safety of camrelizumab, apatinib, pegaspargase (CAPA) and as an intruction immunotherapy with radiotherapy as first-line treatment in patients with de novo stage IE/IIE extranodal natural killer/T-cell lymphoma, nasal type.
Extranodal natural killer/T-cell lymphoma (ENKTCL), nasal type, is a rare subtype of non-Hodgkin lymphoma (NHL) with relatively high incidence in China. Radiotherapy alone for stage IE/IIE diseases has good response rate but with high relapse rates, ranging from 20-50%. The combination of chemotherapy and radiotherapy improved the long-term survival for patients with stage IE/IIE diseases. But the optimal treatment schedule has not been established. This study is designed with four cycles CAPA induction immunotherapy, followed by 50-56Gy radiotherapy as an approach for stage IE/IIE ENKTCL. The efficacy and safety of this treatment will be measured.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
61
1. Camelirumab 200mg Intravenous injection on day 1. 2. Apatinib 250mg taken orally once daily. 3. Pegaspargase 2000U/m2 Intramuscular injection on day 1.
Sun Yat-sen University
Guangzhou, Guangdong, China
Shanghai Eye Ear Nose and Throat Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Department of Hematology, Xinhua hospital
Shanghai, Shanghai Municipality, China
Rate of complete response at week 24
Rate of patients with complete response (CR) at week 24 evaluate by Lugano 2014 criteria
Time frame: 24 weeks
Rate of overall response rate at week 24
Rate of patients with complete response and partial response (ORR) at week 24 evaluate by Lugano 2014 criteria
Time frame: 24 weeks
Rate of overall survival at 2 years
overall survival rate (OS) of patients at 2 years
Time frame: 2 years
Rate of progression free survival at 2 years
progression free survival rate (PFS) of patients at 2 years
Time frame: 2 years
percent of adverse events
adverse events graded by NCI CTCAE Ver4.03
Time frame: 2 years
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