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This is an open-label, single-center, nonrandomized, Phase 2 study to evaluate efficacy and safety of SHR-1210 combined with Apatinib in subjects with relapsed or refractory NK/T cell lymphoma.Efficacy will be assessed every 8 weeks according to 2014 Lugano criteria.Safety evaluations (both clinical and laboratory) are performed at baseline, before each study treatment, and throughout the study.
The primary objective of this phase 2 study is to assess objective response rate of SHR-1210 combined with Apatinib in patients with relapsed or refractory NK/T cell lymphoma. The secondary objective is to observe time to response,progression free survival rate at 2 years,overall survival rate at 2 years,safety and immunogenicity of SHR-1210 combined with Apatinib in relapsed or refractory NK/T cell lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR1210 +Apatinib | Experimental | SHR-1210 injection, 200 mg/dose, intravenous infusion within 20-60 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR1210 | Drug | SHR-1210 injection, 200 mg/dose, intravenous infusion within 20-60 minutes. Apatinib oral administration, 500mg per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| objective response rate | rate of subjects achieved complete response plus partial response in all evaluable subjects | from first patient first visit to 6 month after last patient first visit |
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Inclusion Criteria:
6.Life expectancy ≥ 12 weeks.; 7.Adequate laboratory parameters during the screening period as evidenced by the following:
a.Absolute neutrophil count ≥ 1.5× 109/L ; b.Platelets ≥ 100 × 109/L; c.Hemoglobin ≥ 9.0 g/dL; d.Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN), ALT and AST ≤ 2.5×ULN e.Serum Creatinine ≤1.25×ULN or Creatinine clearance≥45 mL/min; f.Coagulation function index:INR ≤1.5×ULN,APTT≤1.5×ULN 8.Women of childbearing potential must be willing and able to employ a highly effective method of birth control/contraception to prevent pregnancy while on treatment and for at least 120 days after receiving the last dose of study treatment. Women of childbearing potential with pregnancy test negative within 7days before entering the group and not in in lactation; Male subjects with WOCBP partner should receive Surgical sterilization orconsent to employ a highly effective method of birth control/contraception to prevent pregnancy while on treatment and for at least 120 days after receiving the last dose of study treatment.
9.Able to understand and sign an informed consent form (ICF).
Exclusion Criteria:
Known central nervous system lymphoma
Haemophilus cell syndrome at diagnosis
Large lung vessels were involved
History and complication
laboratory test
Other factors that may lead to the study termination, such as severe disease or abnormal laboratory tests or family or social factors affecting subjects safety or test data and sample collection
Women suffering from pregnancy or lactation.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuqin Song | Contact | +13683398726 | songyuqin622@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yuqin Song | Cancer Hospital of Beijing University | Principal Investigator |
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| ID | Term |
|---|---|
| D054391 | Lymphoma, Extranodal NK-T-Cell |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| C553458 | apatinib |
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| D009369 |
| Neoplasms |