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)
NCT ID: NCT04365036
Last Updated: 2025-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
207 participants
INTERVENTIONAL
2020-05-03
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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toripalimab with P-GemOx
Patients will receive toripalimab and induction chemotherapy with pegaspargase, gemcitabine, oxaliplatin, every 3 weeks for 4 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) will be given. Concurrent toripalimab of 240mg will be administered every 3 weeks for 3 cycles during IMRT. Toripalimab 240mg will be given every 3 weeks for 13 cycles, started on day 1 of induction chemotherapy.
Toripalimab
toripalimab 240mg, d1, intravenous drip
Pegaspargase
pegaspargase, 2000U/m2, d1, intravenous drip
Gemcitabine
gemcitabine, 1000mg/m2, d1,d8, intravenous drip
Oxaliplatin
oxaliplatin, 130mg/m2, d1, intravenous drip,
Definitive intensity-modulated radiotherapy (IMRT)
Definitive intensity-modulated radiotherapy (IMRT) of 54-56Gy will be given in 25\~26 days
P-GemOx
Patients will receive induction chemotherapy with pegaspargase, gemcitabine, oxaliplatin, every 3 weeks for 4 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) will be given.
Pegaspargase
pegaspargase, 2000U/m2, d1, intravenous drip
Gemcitabine
gemcitabine, 1000mg/m2, d1,d8, intravenous drip
Oxaliplatin
oxaliplatin, 130mg/m2, d1, intravenous drip,
Definitive intensity-modulated radiotherapy (IMRT)
Definitive intensity-modulated radiotherapy (IMRT) of 54-56Gy will be given in 25\~26 days
Interventions
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Toripalimab
toripalimab 240mg, d1, intravenous drip
Pegaspargase
pegaspargase, 2000U/m2, d1, intravenous drip
Gemcitabine
gemcitabine, 1000mg/m2, d1,d8, intravenous drip
Oxaliplatin
oxaliplatin, 130mg/m2, d1, intravenous drip,
Definitive intensity-modulated radiotherapy (IMRT)
Definitive intensity-modulated radiotherapy (IMRT) of 54-56Gy will be given in 25\~26 days
Eligibility Criteria
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Inclusion Criteria
* 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
* involvement of central nervous system;
* previously received treatment of chemotherapy, radiotherapy, immunotherapy or biotherapy for lymphoma；
18 Years
75 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Qingqing Cai
Chief physician
Locations
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Guangdong General Hospital
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Wenyu Li, MD
Role: primary
Other Identifiers
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B2020-040-01
Identifier Type: -
Identifier Source: org_study_id
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