sintilimab,pegaspargase,gemcitabine,oxaliplatin: All patients enrolled in the study will accept sintilimab with P-GemOx (pegaspargase, gemcitabine and oxaliplatin) regimens their first-line therapy.
Patients with CR or PR will receive sintilimab maintenance therapy
Study summary
The purpose of this multi-center,single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of Sintilimab with P-GemOx (pegaspargase, gemcitabine and oxaliplatin) regimen for newly diagnosed advanced extranodal natural killer/T-cell lymphoma, nasal type (ENKTL)
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* biopsy proved extranodal natural killer/T-cell lymphoma, nasal type;
* newly diagnosed stage III/IV patients;
* at least one evaluable lesion；
* ECOG PS 0-2;
* 18-75 years; without other malignancy;
* proper functioning of the major organs.
Exclusion Criteria:
* hemophagocytic syndrome or aggressive NK cell leukemia;
* involvement of central nervous system;
* previously received treatment of chemotherapy, radiotherapy, immunotherapy or biotherapy for lymphoma；
Primary outcome measure(s)
complete remission (CR) rate — 2years
overall response rate (ORR) — 2years
Trial sites (1)
Facility
City
Region
Status
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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