ENKTCL
Conditions
Interventions
Group 1:Tislelizumab in combination with gemcitabine and oxaliplatin
Sponsors
Jiangsu Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patient with histologically proven relapsed or refractory ENKTCL; 2. Relapsed or primary refractory NK/T-cell lymphoma, nasal type after first-line aspargase-containing therapy 3. There is at least one imaging measurable lesion; 4. ECOG 0-2; 5. Aged 18 to 75 years; 6. No other malignancy; 7. Normal function of major organs; 8.Women of childbearing potential (WOCBP) who have a negative pregnancy test within 7 days prior to enrollment and agree to practice highly effective contraception to prevent pregnancy for at least 1 year after receiving study treatment; male subjects with WOCBP partners should be surgically sterilized or agree to practice highly effective contraception to prevent pregnancy for at least 1 year after receiving study treatment ; 9.Able to understand the purpose and risks of the study and provide signed and dated informed consent form.
Exclusion criteria
Exclusion criteria: 1. Hemophagocytic syndrome or aggressive NK cell leukemia; 2. Involvement of the central nervous system; 3. Patients who have previously used PD1 or PDL1 antibodies ineffective; 4. Received anti-tumor vaccine or other immunostimulatory anti-tumor therapy within 3 months before the first administration of the test drug; 5. Participate in other clinical studies or within 4 weeks before the end of the clinical trial; 6. Uncontrolled interstitial pneumonia; 7. Received chemotherapy, radiotherapy, immunotherapy, including local therapy within 4 weeks. Adverse reactions (except alopecia) related to previous anti-tumor therapy have not recovered to CTC AE = 500 IU/mL) and hepatitis C (HCV RNA positive, abnormal liver function) 10. Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or the evaluation of the study results; 11. Lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| best complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| the rate of PFS at sixth month;safety;overall response rate; | — |
Countries
China
Contacts
Public ContactFan Lei
Jiangsu Provincial People's Hospital
Outcome results
None listed