Clinical trial · Interventional
Sintilimab With P-GemOx Regimen for Newly Diagnosed Advanced Extranodal Natural Killer/T-cell Lymphoma, Nasal Type
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
NCT04127227CI-TRIAL-00104504active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NK/T Cell Lymphoma Nos | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sintilimab,pegaspargase,gemcitabine,oxaliplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sintilimab With P-GemOx
- description
- 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.
- interventionNames
- Drug: sintilimab,pegaspargase,gemcitabine,oxaliplatin
Primary outcomes (2)
- measure
- complete remission (CR) rate
- timeFrame
- 2years
- measure
- overall response rate (ORR)
- timeFrame
- 2years
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * biopsy proved extranodal natural killer/T-cell lymphoma, nasal type; * newly diagnosed stage III/IV 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；
References
Publications (1)
- DERIVEDTian 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. PMID 38554717