Sintilimab With P-GemOx (Pegaspargase, Gemcitabine and Oxaliplatin) Regimen for Newly Diagnosed Advanced Extranodal Natural Killer/T-cell Lymphoma, Nasal Type (ENKTL): a Single Arm, Open, Multicenter, Phase II Study
Sponsor study identifier
interventional
34
1 country
1
Study Start
October 9, 2019
Actual (reported)Primary Completion
July 20, 2023
Actual (reported)Study Completion
October 9, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The purpose of this multi-center,single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of Sintilimab with P-GemOx (pegaspargase, gemcitabine and oxaliplatin) regimen for newly diagnosed advanced 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.
October 9, 2027
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.
October 9, 2019
Actual (reported)October 10, 2019
Actual (reported)October 15, 2019
Actual (reported)July 20, 2023
Actual (reported)October 9, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
complete remission (CR) rate
2years
overall response rate (ORR)
2years
overall survival (OS)
2years
progression survival (PFS)
2years
disease-free survival (DFS)
2years
bio-marker analysis
2years
Sintilimab, 200mg, d1, intravenous drip; pegaspargase, 2000U/m2, d1, intravenous drip; gemcitabine, 1000mg/m2, d1,d8, intravenous drip; oxaliplatin, 130mg/m2, d1, intravenous drip; All patients received up to 6 treatment cycles of 21 days. Patients with CR or PR will receive Sintilimab maintenance therapy.
All patients enrolled in the study will accept sintilimab with P-GemOx (pegaspargase, gemcitabine and oxaliplatin) regimens their first-line therapy. Patients with CR or PR will receive sintilimab maintenance therapy
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
sintilimab,pegaspargase,gemcitabine,oxaliplatin
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordSun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 51000, China
Tian XP, Cai J, Xia Y, Zhang YC, Wang L, Liu PP, Huang HQ, Li YJ, Zhou H, Li ZM, Yang J, Wei LQ, Zou QH, Huang Y, Li J, Ling L, Zhong WL, Cai QQ. First-line sintilimab with pegaspargase, gemcitabine, and oxaliplatin in advanced extranodal natural killer/T cell lymphoma (SPIRIT): a multicentre, single-arm, phase 2 trial. Lancet Haematol. 2024 May;11(5):e336-e344. doi: 10.1016/S2352-3026(24)00066-8. Epub 2024 Mar 27.
34 participants (actual enrollment reported by the registry).
First Submitted
October 10, 2019
First Posted
October 15, 2019
Study Start
October 9, 2019
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
July 20, 2023
Actual (reported)Study Completion
October 9, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
March 3, 2026
Record last verified: 2026-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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