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

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Eye & ENT Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: —

Summary

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.

Conditions

• ORR
• OS
• PFS

Timeline

• Start date: 2024-09-12
• Primary completion: 2027-07-31
• Completion: 2027-12-31
• First posted: 2026-03-04
• Last updated: 2026-03-04

Locations

1 site across 1 country: China