NCT07574528Not yet recruitingPhase 2
A Multicenter, Single-Arm, Phase II Study of Sintilimab, Pegaspargase and Selinexor Followed by Radiotherapy in Newly Diagnosed Stage I/II Extranodal NK/T-Cell Lymphoma
Sun Yat-sen University1 site in 1 country47 target enrollmentStarted: May 6, 2026Last updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 47
- Locations
- 1
Study Overview
Brief Summary
This is a single-arm, open-label, multicenter phase II study evaluating sintilimab, pegaspargase, and selinexor followed by radiotherapy as first-line treatment for patients with newly diagnosed stage I/II extranodal natural killer/T-cell lymphoma (ENKTL).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18 years or older.
- •No prior systemic treatment for lymphoma, except short-term corticosteroids for symptom control.
- •Life expectancy of more than 3 months.
- •Eastern Cooperative Oncology Group performance status of 0 to
- •Histologically confirmed extranodal natural killer/T-cell lymphoma.
- •Primary lesion located in the nasal cavity or upper aerodigestive tract.
- •Stage I to II disease.
- •At least one measurable or evaluable lesion according to Lugano 2014 criteria.
- •Adequate organ and bone marrow function.
Exclusion Criteria
- •Aggressive NK-cell leukemia.
- •Significant dysfunction of major organs.
- •Known hypersensitivity to any study drug or its components, or contraindication to any study treatment.
- •Pregnant or breastfeeding women, or participants of childbearing potential unwilling to use effective contraception.
- •Known history of human immunodeficiency virus infection or acquired immunodeficiency syndrome.
Investigators
Qingqing Cai
Professor and Chief Physician
Sun Yat-sen University
Study Sites (1)
Loading locations...
Similar Trials
Recruiting
Phase 2
Sintilimab Combined With Anlotinib and Taxane-Based Chemotherap for Recurrent/Metastatic Nasopharyngeal CarcinomaNCT07581821Ming-Yuan Chen33
Not yet recruiting
Not Applicable
Sintilimab, Chidamide, and Azacitidine for Untreated Stage I-II Extranodal NK/T-Cell LymphomaComplete Remission Rate， CRRProgression Free SurvivalOverall SurvivalAdverse EventDuration of ResponseNCT07542912Sun Yat-sen University30
Completed
Phase 2
Phase II, Open-Label Study of preliminary efficacy of Sitravatinib in Combination with Tislelizumab in Patients with Metastatic Uveal Melanoma with liver metastases.2024-519451-29-00Grupo Espanol Multidisciplinar De Melanoma16
Recruiting
Phase 3
Becotatug Vedotin Plus Sintilimab in Locoregionally Advanced NPCNCT07459296First Affiliated Hospital of Guangxi Medical University266
Not yet recruiting
Phase 2
Sintilimab-Nimotuzumab Induction Followed by Chemoradiation-Nimotuzumab in LA-HNSCC: Single-Arm Phase IINCT07310771Fujian Cancer Hospital23