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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: PFS; OS; ORR

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

Study Locations

• China
  • China
    • Shanghai, China, China, 200000
      • EENT hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

This study was conducted in patients with primary stage I-II NK/ T-cell lymphoma (subjects must have a measurable tumor lesion at baseline).

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	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.	At 14 weeks after treatment initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	progression free survival; It refers to the time between the start of treatment and the onset of disease progression or death from any cause	up to 5 year

Collaborators and Investigators

• Sponsor: Eye & ENT Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: September 13, 2024
• First Submitted That Met QC Criteria: February 27, 2026
• First Posted (Actual): March 4, 2026

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2024071