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)

Launched by SUN YAT-SEN UNIVERSITY · Apr 24, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the effects of two different treatment approaches for patients with a type of cancer called early-stage extranodal natural killer/T-cell lymphoma, nasal type (ENKTL). Researchers want to find out if adding a medication called toripalimab, which is a type of immunotherapy that helps the body’s immune system fight cancer, makes the standard treatment of chemotherapy and radiation more effective and safer for patients. This trial is currently looking for participants aged 18 to 75 who have just been diagnosed with this cancer and meet specific health criteria.

To participate, individuals must have a confirmed diagnosis of ENKTL, be in the early stages of the disease (stage I or II), and have at least one measurable tumor. Those interested in joining will receive either the standard treatment or the same treatment plus toripalimab. Throughout the trial, participants will be monitored closely to assess how well the treatments work and to check for any side effects. This trial is important because it could help improve treatment options for patients with this rare type of lymphoma.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • biopsy proved extranodal natural killer/T-cell lymphoma, nasal type;
• • newly diagnosed stage I/II patients;
• • at least one evaluable lesion；
• • ECOG PS 0-2;
• • 18-75 years; without other malignancy;
• • proper functioning of the major organs.
• Exclusion Criteria:
• • hemophagocytic syndrome or aggressive NK cell leukemia;
• • involvement of central nervous system;
• • previously received treatment of chemotherapy, radiotherapy, immunotherapy or biotherapy for lymphoma；