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Sintilimab with P-GEMOX in Newly Diagnosed Advanced ENKTL
NCT06583083Phase 2
Key facts
- Status
- Recruiting
- Start
- Oct 2024
- Primary completion
- Aug 2026
- Countries
- 1
- Sponsor
- Sun Yat-sen University
- Modality
- Monoclonal Antibodies
- Drugs
- sintilimab
- Conditions
- extranodal natural killer T cell lymphoma (ENKTL)
01
Overview
Phase 2, randomised trial of sintilimab in extranodal natural killer T cell lymphoma (ENKTL) (2 arms), sponsored by Sun Yat-sen University. Primary endpoint: Progression-Free Survival up to 4 years. Started Oct 2024; status: recruiting.
02
Design
2 arms- Study design
- Randomized
experimental group
Sintilimab intravenous drip, Pegaspargase intramuscular injection, gemcitabine intravenous drip, oxaliplatin intravenous drip
control group
Pegaspargase intramuscular injection, gemcitabine intravenous drip, oxaliplatin intravenous drip
03
Who it enrols
Adults with newly diagnosed, advanced-stage extranodal NK/T-cell lymphoma with at least one measurable lesion, adequate organ function, and life expectancy >3 months. Excludes patients with CNS involvement, aggressive NK-cell leukemia, active infections, or HIV.
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Endpoints
Primary
Progression-Free Survival
Secondary
Objective Response Rate
Complete Response Rate
Overall Survival
Adverse Events
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