Advanced extranodal NK/T cell lymphoma
Conditions
Interventions
Experimental group:asparaginase combined with etoposide, high-dose methotrexate and PD-1 monoclonal antibody
Sponsors
Union Medical College Affiliated Hospital of Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-70 years old, ECOG score 0-2. 2. Estimated survival time > 6 months. 3. The pathological tissue was first diagnosed as extranodal NK/T cell lymphoma. 4. CA stage III and IV patients. 5. Acceptable hematological indicators, no chemotherapy contraindications, absolute neutrophils >= 1.0 × 10 ^ 9 / L, PLT >= 75 x 10 ^ 9 / L, hemoglobin >= 80g/L (except for patients with bone marrow infiltration of lymphoma). 6. There is at least one measurable lesion. For intranodal lesions, it is defined as long diameter >= 1.5cm and short diameter >= 1.0cm, and for extranodal lesions, long diameter should be >= 1.0cm. 7. Liver function: TBIL <= 1.5 x ULN; ALT or AST <= 2.5 x ULN; patients with non-bone invasion alkaline phosphatase <= 3 x ULN. 8. Renal function: serum creatinine <= 1.5 x ULN. 9. Excluding other major diseases, the heart function is normal. 10 female and male patients of childbearing age and their spouses are willing to use adequate contraception throughout the study, and female patients of childbearing age must be negative for serum pregnancy test within 7 days before the first administration. 11 the subjects voluntarily participated in the clinical trial, signed the informed consent form, and cooperated with the follow-up. twelve. No other related treatments include traditional Chinese medicine (anti-tumor), immunotherapy, biological agent therapy (except for anti-bone metastasis and other symptoms). 13. Be able to understand this study and sign an informed consent form before screening.
Exclusion criteria
Exclusion criteria: 1. Patients with definite neuropathy or psychosis, including dementia or epileptic seizures, a history of psychotropic substance abuse and cannot be abstained from, or other substantial lesions that may increase central nervous system toxicity; 2. Participating in other clinical trials or participating in other clinical investigators 4 weeks before enrollment (except those who have not received treatment); 3. Systemic autoimmune disease or immunodeficiency; 4. Refuse to collect blood samples; 5. Allergic to any of the drugs in the program; 6. Lactating women; 7. Major diseases and uncontrolled active infections that can cause experimental interference; 8. Contraindications of chemotherapy; 9. Within 28 days of using PD-1/high-dose MTX/pegaspargase/etoposide; 10. The researchers believe that it is not suitable for inclusion.; 11. Known active bacterial, viral, fungal, mycobacterial, parasitic or other infections within 4 weeks before enrollment (excluding nail bed skin fungal infections); 12. Application of other anti-tumor treatments (such as radiotherapy, chemotherapy, hormone therapy, biological therapy, immunotherapy); 13. Hemophagocytic syndrome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Response rate; | — |
Countries
China
Contacts
Public ContactZhang Liling
Cancer Center of Union Medical College Affiliated Hospital of Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed