Actively Recruiting
Screening Study of Combined Sequential Chemotherapy and Radiation Therapy for Early-stage NK/T-cell Lymphoma
Led by Fudan University · Updated on 2026-04-09
210
Participants Needed
7
Research Sites
251 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Screening Study of Combined Sequential Chemotherapy and Radiation Therapy for Early-stage NK/T-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with extranodal NK/T-cell lymphoma, nasal type (NKTCL) confirmed by pathology according to WHO-2016 criteria
- Primary tumor located in the upper respiratory and digestive tract (nasal cavity, sinuses, nasopharynx, oropharynx, or oral cavity) with clinical stage IE or IIE based on PET/CT and bone marrow exam per Lugano 2014 criteria
- At least one measurable lesion or lesion assessable by PET/CT according to lymphoma response criteria
- No previous chemotherapy, radiotherapy, immunotherapy, or biological therapy for lymphoma
- Age between 18 and 75 years, all genders
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Adequate organ and bone marrow function, including neutrophil count ≥1.0x10^9/L, platelet count ≥75x10^9/L, hemoglobin ≥90 g/L without recent growth factor or transfusion
- Liver function with total bilirubin ≤1.5 times upper limit of normal and ALT/AST ≤2 times upper limit of normal
- Renal function with serum creatinine ≤1.5 times upper limit of normal
- Coagulation function with plasma fibrinogen ≥1.5 g/L
- Cardiac function with left ventricular ejection fraction ≥50%, no recent acute myocardial infarction, arrhythmia, or atrioventricular conduction block grade I or above
- Willingness to follow study procedures, follow-up, and laboratory tests
You will not qualify if you...
- Co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV), or hepatitis B virus (HBV) with plasma HBV-DNA >10^3/ml
- History of pancreatitis
- Acute or systemic infections requiring intravenous antibiotics
- Severe complications such as hemophagocytic syndrome or disseminated intravascular coagulation
- Significant organ dysfunction including respiratory failure, chronic congestive heart failure NYHA class ≥2, decompensated liver or kidney disease, uncontrolled hypertension or diabetes, recent cardiovascular thrombotic or bleeding events within 6 months
- History of autoimmune diseases not suitable for immune checkpoint inhibitor treatment
- Pregnant or breastfeeding women
- Psychiatric disorders
- Allergy to any drugs used in the chemotherapy regimens
- Other tumors requiring surgery or chemotherapy within the past 6 months
- Current use of other experimental drugs
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Cancer Hospital of Fujian Province
Fuzhou, Fujian, China, 350003
Actively Recruiting
2
Nantong Cancer Hospital
Nantong, Jiangsu, China, 226006
Actively Recruiting
3
Shanghai Eye Ear Nose and Throat Hospital，Fudan University
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
4
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
5
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200092
Actively Recruiting
6
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
7
People's Hospital of Ningbo University
Ningbo, Zhejiang, China
Actively Recruiting
Research Team
R
Rong Tao, MD
CONTACT
C
Chuanxu Liu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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