Sintilimab, Pegaspargase Plus GemOx for Untreated Extranodal NK/T-Cell Lymphoma

PHASE2RecruitingINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

May 20, 2024

Primary Completion Date

May 20, 2026

Study Completion Date

May 20, 2027

Conditions
Extranodal NK/T-cell Lymphoma
Interventions
DRUG

Immunochemotherapy

"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."

Trial Locations (1)

100730

RECRUITING

Peking Union Medical College Hospital, Beijing

All Listed Sponsors
lead

Peking Union Medical College Hospital

OTHER