Extranodal nasal-type NK/T cell lymphoma
Conditions
Interventions
Case series:PD-1 in combination with albumin bound paclitaxel
Sponsors
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. voluntarily participate in and sign the informed consent; 2. aged 18 to 70 years; 3. life expectancy >=3 months; 4. physical condition score ECOG 0 ~ 2; 5. pathological diagnosis of extranodal NK/T cell lymphoma (nasal type); 6. previous chemotherapy regiments based on drugs containing asparaginase (including l-asparaginase or permenudase) must be accepted, in which stage I and II subjects need to receive radiotherapy; 7. subjects must be recurrent (defined as disease progression confirmed after remission of recent treatment) or refractory (defined as partial remission not achieved after 4 cycles of treatment, or complete remission not achieved after 6 cycles of treatment, or complete remission not achieved after autologous hematopoietic stem cell transplantation;If the best curative effect or the end cause is PD, the number of cycles is not required) of ENKTL; 8. subjects must have a measurable lesion, defined as: the longest diameter of lymph node lesion in CT cross-sectional image (>, 1.5cm) or the longest diameter of extranodal lesion (>, 1.0cm);FDG-PET positive lesions; 9. no serious organ dysfunction (main organ: heart, lung, liver, kidney) (referring to the respective standards); 10. blood routine index: white blood cell (WBC) >=3x10^9/L;Neutrophil absolute count (ANC) >=1.5x10^9/L; Platelets (PLT) >=100x10^9/L;Hemoglobin (Hgb) >=9 g/dL; 11. blood biochemical indicators: AST (SGOT), ALT (SGPT) <=2.5 ULN(in the absence of liver invasion) or <=5 ULN (in the presence of liver invasion); Total bilirubin (TBIL) <=1 ULN; Serum creatinine (CRE) <=1.5 ULN; 12. coagulation function: prothrombin time (PT), INR <=1.5 ULN (unless warfarin anticoagulation is being used); 13. able to comply with the research visit plan and other program requirements; 14. women at risk of pregnancy must have a negative serum pregnancy test 7 days before the first dose and be willing to use a highly effective method of contraception during the trial and 90 days after the last dose (approximately 5 drug half-life + menstrual cycle).For male subjects whose partners are women who are likely to become pregnant, they should be sterilized by surgery, or they should agree to use a highly effective method of contraception during the trial and 120 days after the last administration of the test drug (approximately 5 drug half-life + sperm emptycycle).
Exclusion criteria
Exclusion criteria: 1. Invasive NK cell leukemia or prodromal NK cell tumor; 2. Known to have central nervous system (CNS) lymphoma; 3. At the initial diagnosis of ENKTL, there was hemophagocytic syndrome; 4. The lesion invaded the great pulmonary vessels; 5. History and complications; 1) received anti-tumor vaccine or cellular immunotherapy within 3 months prior to the first dose of the study drug; 2) previous treatment with anti-pd-1 antibody, anti-pd-l1 antibody, anti-pd-l2 antibody or anti-ctla-4 antibody (or any other antibody acting on the T cell synergistic stimulation or checkpoint pathway); 3) the patient is participating in other interventional clinical studies or is less than 4 weeks away from the end of treatment of the previous clinical study; 4) those who are less than 4 weeks away from the last anti-tumor treatment (radiotherapy, chemotherapy, targeted therapy, immunotherapy, or local-regional treatment);Patients whose adverse reactions related to anti-tumor treatment (except hair loss) did not recover to nci-ctc AE10 mg/ day prednisone or equivalent dose of other glucocorticoids) or other immunosuppressants within 14 days prior to the first dose of the study drug.In the absence of active autoimmune disease, inhaled or topical use of steroid and prednisone therapeutic dose of > 10 mg/ day is permitted; 8) patients with known history of interstitial pneumonia or highly suspected interstitial pneumonia;Or patients who may interfere with the detection or management of suspected drug-related pulmonary toxicity; 9) history of malignant tumors.Patients with basal cell carcinoma of the skin, superficial bladder carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ, who underwent possible curative treatment and were free of disease recurrence within 5 years after treatment were excluded; 10) history of organ transplantation and allogeneic hematopoietic stem cell transplantation; 11) for subjects who have undergone major surgery or suffered severe trauma, the elimination of the effects of surgery or trauma is less than 14 days before enrollment; 12) patients with active tuberculosis should be excluded.Patients with suspected active TB should be examined for chest x-rays, sputum, and excluded by clinical signs and symptoms.Patients with a history of active pulmonary tuberculosis infection within the previous 1 year should be excluded even if they have been treated.Patients with a history of active TB infection more than 1 year ago should also be excluded, unless the previously used anti-tb treatment course and type are proved to be appropriate; 13) severe acute or chronic infections requiring systemic treatment; 14) patients with heart failure (New York heart association standard grade III or IV) and despite appropriate medication, poor control of coronary artery disease or poorly controlled arrhythmia, or a history of myocardial infarction within the previous 6 months were scr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Countries
China
Contacts
Public ContactHuangming Hong
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Outcome results
None listed