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)

NCT04365036 · Sun Yat-sen University

Recruiting

In plain English

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About this study

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 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；

Study design

Enrollment target: 207 participants

Allocation: randomized

Masking: none

Age groups: adult, older_adult

Timeline

Starts: 2020-05-03

Estimated completion: 2028-12-31

Last updated: 2025-03-13

Interventions

Drug: ToripalimabDrug: PegaspargaseDrug: GemcitabineDrug: OxaliplatinRadiation: Definitive intensity-modulated radiotherapy (IMRT)

Primary outcomes

• progression free survival (PFS) (3 years)

Sponsor

Sun Yat-sen University · other

Contacts & investigators

ContactQingqing Cai, MD · contact · caiqq@sysucc.org.cn · 0086-20-87342823

All locations (1)

Guangdong General HospitalRecruiting

Guangzhou, Guangdong, China

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