RecruitingPhase 3NCT04365036

A Multicenter, Phase 3, Randomized Trial of Sequencial Chemoradiotherapy with or Without Toripalimab (PD-1 Antibody) in Newly Diagnosed Early-Stage Extranodal Natural Killer/T Cell Lymphoma, Nasal Type (ENKTL)


Sponsor

Sun Yat-sen University

Enrollment

207 participants

Start Date

May 3, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this randomized, multi-center,phase Ⅲ clinical trail is to compare the safety and efficacy of sequencial chemoradiotherapy with or without toripalimab (PD-1 antibody) for newly diagnosed early-stage extranodal natural killer/T-cell lymphoma, nasal type (ENKTL)


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding an immunotherapy drug (toripalimab, a PD-1 antibody that helps the immune system fight cancer) to standard chemotherapy and radiation improves outcomes for patients with newly diagnosed early-stage natural killer/T-cell lymphoma (ENKTL), a rare type of lymphoma that most commonly affects the nose and upper throat. **You may be eligible if:** - You have a confirmed diagnosis of early-stage (stage I or II) extranodal NK/T-cell lymphoma, nasal type - You have not received any prior treatment for this lymphoma - You have at least one measurable area of disease on scans - You are in reasonably good health (ECOG performance status 0–2) - You are 18 to 75 years old - Your major organs (heart, kidneys, liver) are functioning adequately **You may NOT be eligible if:** - You have a severe complication of lymphoma called hemophagocytic syndrome or aggressive NK cell leukemia - Your lymphoma has spread to the central nervous system (brain or spinal cord) - You have previously received chemotherapy, radiation, immunotherapy, or other cancer treatments for this condition Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGToripalimab

toripalimab 240mg, d1, intravenous drip

DRUGPegaspargase

pegaspargase, 2000U/m2, d1, intravenous drip

DRUGGemcitabine

gemcitabine, 1000mg/m2, d1,d8, intravenous drip

DRUGOxaliplatin

oxaliplatin, 130mg/m2, d1, intravenous drip,

RADIATIONDefinitive intensity-modulated radiotherapy (IMRT)

Definitive intensity-modulated radiotherapy (IMRT) of 54-56Gy will be given in 25\~26 days


Locations(1)

Guangdong General Hospital

Guangzhou, Guangdong, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04365036