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

NCT06314334 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2026-04-09

No results posted yet for this 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.

Conditions

  • Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type

Interventions

DRUG

Sintilimab+Pegaspargase

1. Sintilimab, 200mg intravenous drip, on day 1; 2. pegaspargase, 2000U/m\^2, capped at 3750U, intramuscular, day 1;

DRUG

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

DRUG

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.

RADIATION

IMRT

Intensity modulated radiotherapy (50-56Gy)

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Rong Tao, MD · Fudan Cancer Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-04
Primary Completion
2026-12-30
Completion
2028-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06314334 on ClinicalTrials.gov