Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT06314334
Eligibility Criteria:
Inclusion Criteria:
* Patients who meet the diagnostic criteria for NKTCL (WHO-2016) based on pathological examination.
* Primary lesions located in the upper respiratory and digestive tract such as the nasal cavity, sinuses, nasopharynx, oropharynx, or oral cavity, with clinical staging of IE/IIE based on PET/CT and bone marrow examination according to the Lugano 2014 criteria.
* Evaluated for lymphoma response according to the Lugano 2014 criteria, with at least one measurable lesion or lesion assessable by PET/CT.
* No prior treatment with chemotherapy, radiotherapy, immunotherapy, or biological therapy for lymphoma.
* Age between 18 and 75 years, both genders.
* Eastern Cooperative Oncology Group performance status (ECOG) score of 0-2.
* Must have adequate organ and bone marrow function, defined as follows:
Hematology: Absolute neutrophil count (ANC) ≥1.0×10\^9/L, platelet count (PLT) ≥75×10\^9/L, hemoglobin (Hb) ≥90g/L; no administration of granulocyte colony-stimulating factor, platelet transfusion, or red blood cell transfusion in the previous 14 days.
Liver function: Total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2×ULN.
Renal function: Serum creatinine (Cr) ≤1.5×ULN. Coagulation function: Plasma fibrinogen ≥1.5g/L. Cardiac function: Left ventricular ejection fraction (LVEF) ≥50%, no acute myocardial infarction, arrhythmia, or atrioventricular conduction block of grade I or above on electrocardiogram.
* Willing to comply with the study protocol, follow-up plan, and laboratory and ancillary investigations.
Exclusion Criteria:
* Patients co-infected with HCV, HIV, or HBV with plasma HBV-DNA \>10\^3/ml.
* Patients with a history of pancreatitis.
* Patients with acute or systemic infections requiring intravenous antibiotic therapy.
* Patients with severe complications such as hemophagocytic syndrome, DIC, etc.
* Significant organ dysfunction: such as respiratory failure, chronic congestive heart failure with NYHA class ≥2, decompensated liver or renal dysfunction, uncontrolled hypertension and diabetes despite aggressive treatment, and cardiovascular thrombotic or hemorrhagic events in the past 6 months.
* Patients with a history of autoimmune diseases who are not suitable for treatment with immune checkpoint inhibitors.
* Pregnant and lactating women.
* Patients with psychiatric disorders.
* Known allergies to drugs in the chemotherapy regimen.
* Patients with concomitant other tumors requiring surgery or chemotherapy within the past 6 months.
* Currently using other experimental drugs.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06314334
Study Brief:
Protocol Section:
NCT06314334