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NCT Number: NCT07574528

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

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).

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Key information

Conditions

NKTCL

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, 广东省 - Guangdong Sheng, 510060, China

Location contact

Qingqing Cai

CONTACT

[email protected]

18353201165

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sintilimab

Drug

Sintilimab will be given at 200 mg by intravenous infusion.

pegaspargase

Drug

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

Selinexor

Drug

Selinexor will be given orally once weekly at 60mg.

Radiotherapy

Radiation

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

Primary outcomes

  1. Complete Response Rate (CRR)

    Time frame: 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.

Secondary outcomes

  1. Overall Response Rate (ORR)

    Time frame: Up to approximately 6 months

    The proportion of patients who achieve complete response or partial response, as assessed according to Lugano 2014 response criteria.

  2. Progression-Free Survival (PFS)

    Time frame: Up to 3 years

    The time from enrollment to disease progression or death from any cause, whichever occurs first.

  3. Overall Survival (OS)

    Time frame: Up to 3 years

    The time from enrollment to death from any cause.

  4. Incidence and severity of Adverse Events (AE) and Serious Adverse Event (SAE)

    Time frame: Up to 30 days after the last study treatment

    The incidence and severity of adverse events, assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events.

  5. Change in Quality of Life

    Time frame: Up to 3 years

    Quality of life will be assessed using the EORTC QLQ-C30 or FACT-G questionnaire.

Study contacts

Contact information is provided by the study sponsor or research team.

Qingqing Cai

CONTACT

[email protected]

+8618353201165

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2031
First posted
May 8, 2026
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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