Screening Study of Combined Sequential Chemotherapy and Radiation Therapy for Early-stage NK/T-cell Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFudan University
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Sintilimab+Pegaspargase
- P-GemOx
- GELAD
- IMRT
Treatment groups
210 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov