Screening Study of Combined Sequential Chemotherapy and Radiation Therapy for Early-stage NK/T-cell Lymphoma
Condition(s) studied
Investigational drug(s) / intervention(s)
Sintilimab+Pegaspargase: 1. Sintilimab, 200mg intravenous drip, on day 1; 2. pegaspargase, 2000U/m\^2, capped at 3750U, intramuscular, day 1;
P-GemOx: 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
GELAD: 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.
IMRT: Intensity modulated radiotherapy (50-56Gy)
Study summary
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
Primary outcome measure(s)
- PFS24 — From date of randomization until the date of first documented progression, assessed up to 24 months by the Lugano 2014 response criteria.
Rate of patients with 24-month progression-free survival
Trial sites (7)
| Facility | City | Region | Status |
|---|---|---|---|
| Cancer Hospital of Fujian Province | Fuzhou | Fujian | Recruiting |
| Nantong Cancer Hospital | Nantong | Jiangsu | Recruiting |
| Shanghai Eye Ear Nose and Throat Hospital,Fudan University | Shanghai | Shanghai Municipality | Recruiting |
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | Recruiting |
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | Recruiting |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | Recruiting |
| People's Hospital of Ningbo University | Ningbo | Zhejiang | Recruiting |
More Fudan University trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06314334 on ClinicalTrials.gov ↗ ← All trials in China