extralnodal nature killer/T-cell lymphoma, nasal type
Conditions
Interventions
Group 1:tislelizumab combined with albumin paclitaxel
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Volunteer to participate and sign an informed consent form; 2) Age >= 18 years old and = 3 months; 4) Physical fitness score ECOG 0-2; 5) Pathologically diagnosed as extra-nodal NK/T-cell lymphoma (nasal type) (recommend center consultation for difficult pathology); 6) You must have received a chemotherapy regimen based on L-peaspartase drugs in the past, and subjects in phase I and II need to have received radiotherapy; 7) Subjects must be relapsed (defined as confirmed disease progression after the recent treatment has been remitted) or refractory (defined as failing to achieve partial remission after 4 cycles of treatment, or failing to achieve complete remission after 6 cycles of treatment or autologous hematopoietic stem cell transplantation Complete remission has not been achieved afterwards; if the best effect or the end cause is PD, the number of cycles is not required) ENKTL; 8) There are measurable or/and evaluable lymphoma lesions (non-radiotherapy target areas) (lesions evaluation according to Recist1.1); 9) No serious organs (main organs: heart, lung, liver, kidney) function abnormal (refer to respective standards); 10) Routine blood indicators: white blood cells (WBC) >= 3 x 10^9/L; absolute neutrophil count (ANC) >= 1.5 x 10^9/L; platelets (PLT) >= 100 x 10^9/L; hemoglobin (Hgb) >= 9 g/dL; 11) Blood biochemical indicators: AST (SGOT), ALT (SGPT) <= 2.5 x upper limit of normal (ULN) (in the absence of liver invasion) or <= 5 x upper limit of normal (ULN) (in the case of liver invasion) Bottom); total bilirubin (TBIL) <= ULN; serum creatinine (CRE)<=1.5 x ULN; 12) Blood coagulation function: prothrombin time (PT), international normalized ratio (INR) <= 1.5 x ULN (unless warfarin is being used for anticoagulation); 13) Able to comply with the research visit plan and other program requirements; 14) All patients of childbearing age must agree to take effective contraceptive measures during the study period and within 6 months of stopping treatment. Female patients of childbearing age must have a negative urine pregnancy test before treatment.
Exclusion criteria
Exclusion criteria: 1) Invasive NK cell leukemia or precursor NK cell tumor; 2) Known to have central nervous system (CNS) lymphoma; 3) When ENKTL was first diagnosed with hematopoietic syndrome; 4) Received treatment for lymphoma within 2 weeks before enrollment; 5) Medical history and complications: [1] Anti-tumor vaccine or cellular immunotherapy was used within 3 months before the first dose of study drug was given; [2] Previously received anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-CTLA-4 antibody treatment (or any other antibody that acts on T cell co-stimulation or checkpoint pathway); [3] The patient is participating in other interventional clinical studies or it is less than 4 weeks from the end of the previous clinical study; [4] Those who have been less than 4 weeks from the most recent anti-tumor treatment (radiotherapy, chemotherapy, targeted therapy, immunotherapy or local-regional therapy); adverse reactions related to anti-tumor treatment (except for hair loss) have not recovered to Patients with NCI-CTC AE 10 mg/day of prednisone or equivalent doses of other glucocorticoids) or other immunosuppressive agents for systemic treatment within 14 days before the first dose of study drug. In the absence of active autoimmune diseases, inhaled or topical steroids and adrenal hormone replacement with a dose > 10 mg/day prednisone curative dose are allowed; [8] Patients with a known history of interstitial pneumonia or who are highly suspected of having interstitial pneumonia; or patients who may interfere with the detection or treatment of suspected drug-related lung toxicity; [9] Other active malignant tumors that need simultaneous treatment; [10] With a history of malignant tumors. Except for patients with skin basal cell carcinoma, superficial bladder cancer, skin squamous cell carcinoma or cervical cancer in situ that have undergone possible curative treatment and have not recurred within 5 years after the end of treatment. [11] Known history of organ transplantation and allogeneic hematopoietic stem cell transplantation; [12] Subjects who have undergone major surgery or suffered severe trauma have less than 14 days of elimination of the effects of surgery or trauma before being enrolled; [13] Patients with active tuberculosis need to be excluded. Patients who are suspected of having active TB should be checked for chest X-ray, sputum, and excluded through clinical symptoms and signs. Patients with a history of active tuberculosis infection in the previous year should be excluded even if they have been treated; patients with a history of active tuberculosis infection more than 1 year ago should also be excluded, unless it is proven that the course and types of the previous anti-tuberculosis treatments are all appropriate; [14] Severe acute or chronic infections requiring systemic treatment [15] Suffered from heart failure (New York Heart Association standard grade III or IV) and despite receiving appropriate medical treatment,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objected response rate; | — |
Countries
China
Contacts
Public ContactTongyu Lin
Sichuan Cancer Hospital
Outcome results
None listed