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Enrolling by Invitation

NCT Number: NCT07450040

Efficacy and Safety of Tislelizumab Combined With Gemcitabine and Peraspartase in the Treatment of Patients With Primary Stage I-II NK/T Cell Lymphoma

In the past 10 years, there have been many effective explorations on the treatment of NK/TCL at home and abroad, which has innovated the treatment mode. Since ENKTCL-NT cells are sensitive to radiotherapy, radiotherapy is considered to be the most reliable treatment for ENKTCL-NT. Although patients with radiotherapy alone have excellent short-term efficacy and can achieve CR in 70-97% of patients, the 5-year PFS is only 30.5-61%, with a higher recurrence rate 5,6. The combination of chemotherapy and radiotherapy significantly improved the survival of patients compared with historical controls. Recent studies have shown that the advantage of radiotherapy combined with chemotherapy is that it can significantly reduce the later recurrence of patients with radiotherapy alone. However, the traditional synchronous chemotherapy and radiotherapy have many and serious adverse reactions and poor tolerance in patients, so it cannot be widely applied.

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Key information

Conditions

ORR OS PFS

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

EENT hospital of Fudan University

Shanghai, China, 200000

Who can participate

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

Inclusion criteria

  • Clinical diagnosis of NK/T cell lymphoma .
  • Stage I/II patients .
  • Age 18-70.
  • ECOG score 0-2 points.
  • Sign informed consent.
  • Voluntary compliance with research protocols, follow-up plans, laboratory and auxiliary examinations.

Exclusion criteria

  • Patients with HCV or HIV infection and HBV infection receiving antiviral therapy at the same time are not excluded.
  • Complicated with severe infection requires ICU treatment.
  • There are serious complications such as hemophagic syndrome, DIC, etc.
  • Functional impairment of major organs.
  • A history of autoimmune disease.
  • Pregnant or lactating women.
  • Patients with a history of psychotropic drug abuse who cannot abstain or have mental disorders.
  • Patients who are known to be allergic to drugs used in chemotherapy regimens.
  • Patients with other tumors requiring surgery or chemotherapy within 6 months.
  • Patients who have participated in other clinical trials within 4 weeks prior to the trial;
  • Patients who are taking other investigational drugs.
  • Patients with severe allergic history or allergic constitution.
  • The target lesion has received radiation therapy or surgery (except biopsy);
  • Previously used chemotherapy, immunotherapy or biological targeted therapy for the primary tumor.

Treatment and study plan

Primary outcomes

  1. ORR

    Time frame: At 14 weeks after treatment initiation

    Objective Response Rate; The proportion of patients who achieved pre-specified tumor volume reduction and maintained the minimum time frame required by accepted response evaluation criteria, such as Solid Tumor RECIST Version 1.1.

Secondary outcomes

  1. PFS

    Time frame: up to 5 year

    progression free survival; It refers to the time between the start of treatment and the onset of disease progression or death from any cause

Sponsors and collaborators

Lead sponsor

Eye & ENT Hospital of Fudan University

Other

Registry information

Official study title

A Study on the Efficacy and Safety of Tislelizumab in Combination With Gemcitabine and Sequential Pemetrexed Radiotherapy for Patients With Primary Stage I-II NK/T-Cell Lymphoma

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 4, 2026
Registry last updated
Mar 4, 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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