Sintilimab, Pegaspargase Plus GemOx for Untreated Extranodal NK/T-Cell Lymphoma
Plain-language summary
This trial is testing sintilimab (anti-PD-1) added to the P-GEMOX chemotherapy regimen for patients with extranodal NK/T-cell lymphoma (ENKTL) who have been newly diagnosed and have not yet received treatment. This is a Phase 2 trial, which means researchers are studying how well the treatment works and monitoring for side effects. This trial does not currently have sites in the United States. The trial is currently recruiting patients.
Who can join (key eligibility)
- Age 18 Years to 75 Years years
- Newly diagnosed, not yet treated
- Must be well enough for treatment (adequate performance status)
Final eligibility is determined by the trial team. This list is a starting point only.
What's being tested
Immunochemotherapy (DRUG): P-P-GemOx regimen Sintilimab 200mg iv D1; Pegaspargase 3750U im D1; GemOx regimen: Gemcitabine 1000mg/m2 iv D1, Oxaliplatin 100mg/m2 iv D1 This regimen is administered every 3 weeks. For patients with stage I-II (localized) disease: A sandwich approach incorporating radiotherapy is employed. Patients initially receive 2 cycles of the P-P-GemOx regimen. If the interim evaluation demonstrates a complete response (CR) or partial response (PR), patients will proceed to intensity-modulated radiotherapy (IMRT). Following radiotherapy, an additional 2 cycles of the P-P-GemOx regimen are administered. For patients with stage III-IV (advanced) disease. Patients are planned to receive 6 cycles of the P-P-GemOx regimen. For those achieving CR or PR following 6 cycles of immunochemotherapy, subsequent treatment options include autologous hematopoietic stem cell transplantation (auto-HSCT) or PD-1 monoclonal antibody maintenance therapy, determined based on age and overall physical condition.
Immunochemotherapy
- Treatment length
- Ask the trial team for details
- Visit frequency
- Ask the trial team for details