NCT05254899

Anti-PD-1 Antibody and P-GEMOX Chemotherapy Combined With Radiotherapy in High-risk Early-Stage ENKTL

Anti-PD-1 Antibody and P-GEMOX Chemotherapy Combined With Radiotherapy in High-risk Early-Stage Extranodal NK/T Cell Lymphoma, Nasal Type: A Multi-center Phase II Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The current study is a phase II multi-center single arm trial to evaluate the efficacy and safety of inductive Anti-PD-1+P-GEMOX treatment followed by radiotherapy and concurrent Anti-PD-1 antibody in early-stage high-risk extranodal NK/T cell lymphoma, nasal type

Conditions

• Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type
• Early-stage
• High-Risk Cancer

Interventions

Type	Name	Description
DRUG	Anti-PD-1 monoclonal antibody	200mg iv on Day 1 of each 14-day cycle for 3 cycles in induction treatment; 200mg iv on Day 1,15, 29 during RT treatment
DRUG	Pegaspargase	3000 U/m2 im on Day 2 of each 14-day cycle for 3 cycles in induction treatment
DRUG	Gemcitabine	1g/m2 iv on Day 2 of each 14-day cycle for 3 cycles in induction treatment
DRUG	Oxaliplatin	1g/m2 iv on Day 2 of each 14-day cycle for 3 cycles in induction treatment
RADIATION	Involved site radiotherapy	Involved site radiotherapy according to the ILROG guideline with primary tumor dose of 50-56Gy 14-28 days after inductive therapy

Timeline

• Start date: 2021-10-01
• Primary completion: 2022-09-30
• Completion: 2024-09-30
• First posted: 2022-02-24
• Last updated: 2022-02-24

Locations

1 site across 1 country: China