Plain-language summary

This Phase 2 trial is evaluating Immunochemotherapy as a treatment for people newly diagnosed with NK/T-cell lymphoma. The study measures how well this treatment works and monitors for side effects. This trial does not currently list US sites.

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.

Drugs / treatments

Immunochemotherapy

Treatment length

Ask the trial team for details

Visit frequency

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