NCT04365036|RecruitingPhase 3
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Sponsor study identifier
interventional
207
1 country
1
Study Start
May 3, 2020
Actual (reported)Primary Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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)
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 24, 2020
Actual (reported)April 28, 2020
Actual (reported)May 3, 2020
Actual (reported)December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
progression free survival (PFS)
3 years
complete remission (CR) rate
From the start of treatment with the interventions until 6 months
overall response rate (ORR)
From the start of treatment with the interventions until 6 months
overall survival (OS)
3 years
recurrence-free survival (RFS)
3 years
event free survival (EFS)
3 years
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.
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.
toripalimab 240mg, d1, intravenous drip
pegaspargase, 2000U/m2, d1, intravenous drip
Guangdong General Hospital
Guangzhou, Guangdong, 510000, China
First Submitted
April 24, 2020
First Posted
April 28, 2020
Study Start
May 3, 2020
Actual (reported)Primary Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
gemcitabine, 1000mg/m2, d1,d8, intravenous drip
oxaliplatin, 130mg/m2, d1, intravenous drip,
Definitive intensity-modulated radiotherapy (IMRT) of 54-56Gy will be given in 25\~26 days
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Study Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
March 13, 2025
Record last verified: 2025-03
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Source: ClinicalTrials.gov.
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