Phase II Randomized Study Comparing Combined Chemotherapy and Radiation Treatments for Early-Stage Natural KillerT-Cell Lymphoma

What this Trial Is About

Researchers are studying early-stage extranodal NKT-cell lymphoma, nasal type NKTCL, a fast-growing cancer common in East Asian populations, often linked to EBV infection and mainly affecting the nasal area. The trial aims to compare the effectiveness and safety of three different treatment approaches combining chemotherapy, immunotherapy, and radiotherapy to find the best option for patients. This is a Phase II randomized controlled study focusing on 24-month progression-free survival as the main outcome. Participants are randomly assigned to one of three treatment groups Group A receives four cycles of Sintilimab combined with pegaspargase alongside concurrent radiotherapy Group B undergoes four cycles of PGemOx chemotherapy followed by sequential radiotherapy Group C has two initial cycles of GELAD chemotherapy, then radiotherapy, followed by two additional GELAD cycles. Radiotherapy is delivered as intensity-modulated therapy IMRT with doses of 50-56Gy. During the study, patients are closely monitored with periodic assessments using PETCT scans and bone marrow exams according to Lugano 2014 criteria. Researchers will evaluate progression-free survival over 24 months, along with other outcomes such as response rate at 24 weeks, overall survival, event-free survival, and treatment-related adverse events over up to 60 months. Patients organ function and overall health status are regularly checked to ensure safety throughout the trial period, which may last several years.

Screening Study of Combined Sequential Chemotherapy and Radiation Therapy for Early-stage NK/T-cell Lymphoma