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Clinical Trials in China / NCT07574528
Starting soon Phase 2

A Phase II Study of Sintilimab, Pegaspargase and Selinexor Followed by Radiotherapy in Newly Diagnosed Stage I/II Extranodal NK/T-Cell Lymphoma

NCT07574528 · tracked via the Priya Life Science China tracker
Sponsor
Sun Yat-sen University
Phase
Phase 2
Started
2026-05-06
Last updated
2026-05-08

Condition(s) studied

NKTCL

Investigational drug(s) / intervention(s)

Sintilimab →Pegaspargase →Selinexor →radiotherapy

Sintilimab: Sintilimab will be given at 200 mg by intravenous infusion.

Pegaspargase: Pegaspargase will be given at 2000 U/m², with a maximum total dose of 3750 U, by intramuscular injection.

Selinexor: Selinexor will be given orally once weekly at 60mg.

radiotherapy: Patients will receive induction treatment for up to 4 cycles, followed by radiotherapy.

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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 2. * 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.

Primary outcome measure(s)

  • Complete Response Rate (CRR) — Up to approximately 6 months
    The proportion of patients who achieve complete response at the end of radiotherapy, as assessed according to Lugano 2014 response criteria.

Trial sites (1)

FacilityCityRegionStatus
Sun Yat-sen University Cancer Center Guangzhou 广东省 - Guangdong Sheng

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Endoscopic Nasopharyngectomy for Newly Diagnosed Stage I Nasopharyngeal Carcinoma Patients Recruiting
Predictive Value of Postoperative Circulating Tumor DNA Monitoring for Colorectal Cancer Recurrence Active, not recruiting
A Phase II, Single-Arm, Prospective Trial on the Efficacy and Safety of QL1706 Combination Regimen as Second-Line Therapy for Targeted-Immunotherapy-Resistant Hepatocellular Carcinoma Active, not recruiting

Other trials for the same condition

Adebrelimab Combined With SHR2554 in Relapsed/Refractory PTCL and NK/T-Cell Lymphoma Starting soon
"Selinexor+Pegaspargase+Dexamethasone"in Ⅰ/Ⅱ NKTCL Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07574528 on ClinicalTrials.gov ↗ ← All trials in China