Extranodal NK/T-cell lymphoma, nasal type (NKTCL) is a common malignant tumor in East Asian populations, often starting in the nasal cavity and spreading to other organs. Associated with EBV infection, NKTCL is aggressive. Early-stage patients typically receive chemo and radiotherapy, with promising outcomes. Recent studies show the potential of immune checkpoint inhibitors in NKTCL treatment. However, optimal treatment sequencing and efficacy remain unclear. This study aims to compare three strategies: (A) Pegaspargase with Sintilimab and radiotherapy; (B) chemo then radiotherapy (PGemOx); (C) sandwich chemoradiotherapy (GELAD). The goal is to identify the best treatment based on 24-month progression-free survival.
Extranodal NK/T-cell lymphoma, nasal type (NKTCL) is a malignant hematological tumor that is common in East Asian populations. The disease typically manifests in the nasal cavity in its early stages and can later involve multiple organs throughout the body. Highly associated with EBV infection, NKTCL is known for its aggressive nature. Currently, early-stage patients usually undergo combined treatment with chemotherapy and radiotherapy. Recent studies have shown that combining chemotherapy and radiotherapy containing asparaginase can achieve a complete remission rate (CR) of over 80%, with long-term survival rates exceeding 70% for patients. In recent years, researchers have found that immune checkpoint inhibitors demonstrate high activity in NKTCL, becoming an important therapeutic option. However, it is worth noting that the optimal sequence of chemotherapy and radiotherapy, as well as the effectiveness of combining radiotherapy with immunotherapy, have not been defined. Studies on different treatment strategies have shown variations in treatment-related adverse reactions and compliance with regimens among patients. However, there is currently no prospective randomized controlled study comparing the efficacy and safety of different strategies. Therefore, it is necessary to identify a treatment strategy with good efficacy and tolerability for patients. This study will stratify early-stage NKTCL patients using the NRI scoring system and randomly assign them to three different treatment strategies: (A) asparaginase combined with Sintilimab and synchronous radiotherapy; (B) sequential chemotherapy (PGemOx) followed by radiotherapy ; (C) chemotherapy (GELAD) with sandwiched chemoradiotherapy, to identify the best or worst treatment strategy based on the 24-month progression-free survival rate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
210
1. Sintilimab, 200mg intravenous drip, on day 1; 2. pegaspargase, 2000U/m\^2, capped at 3750U, intramuscular, day 1;
1. pegaspargase 2000U/m\^2, capped at 3750U on day 1, intramuscular; 2. gemcitabine 1.0g/m\^2 on day 1 and day 8, intravenous drip; 3. oxaliplatin 130mg/m\^2 on day 1, intravenous drip
1. gemcitabine 1.0g/m\^2 on day 1, intravenous drip; 2. etoposide 60mg/m\^2 on day 1-3, intravenous drip; 3. pegaspargase 2000U/m\^2, capped at 3750U on day 1,intramuscular; 4. dexamethasone 20mg on day 1-4, intravenous drip.
Intensity modulated radiotherapy (50-56Gy)
Cancer Hospital of Fujian Province
Fuzhou, Fujian, China
RECRUITINGNantong Cancer Hospital
Nantong, Jiangsu, China
RECRUITINGShanghai Eye Ear Nose and Throat Hospital,Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGFudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGXinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGZhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGPeople's Hospital of Ningbo University
Ningbo, Zhejiang, China
RECRUITINGPFS24
Rate of patients with 24-month progression-free survival
Time frame: From date of randomization until the date of first documented progression, assessed up to 24 months by the Lugano 2014 response criteria.
ORR
Overall response rate
Time frame: response rate at 24th week
OS
Overall survival
Time frame: From the time of patient randomization to the end of study, assessed up to 60 months
EFS
Event-free survival
Time frame: From the time of patient randomization to the end of study, assessed up to 60 months
TRAE
Treatment-related adverse event related to the study drug or intervention
Time frame: From the time of patient randomization to the end of study, assessed up to 60 months
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