An Open-lable, Single Arm, Single Center, Phase 2 Study of PD1 Combined With Apatinib in Patients With Relapsed or Refractory NK/T Cell
Overview
- Phase
- Phase 2
- Intervention
- SHR1210
- Conditions
- NK/T-cell Lymphoma
- Sponsor
- Peking University
- Enrollment
- 61
- Primary Endpoint
- objective response rate
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Jun Zhu
Party secretary of Cancer Hospital of Peking University，Director of Internal Medicine
Peking University
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed extranodal NK/T cell lymphoma nasal, PTCL,NOS, AITL, ALCL;
- •Subjects must be recurrent or refractory, and 10-15 white tumors of tumor tissue should be provided.
- •Subjects enrolled have measurable lesion(s) according to Lugano 2014 criteria
- •ECOG performance status of 0 or 1;
- •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
- •Active, known or suspected autoimmune disease. Subjects who were in a stable state without systemic immunosuppressive therapy were admitted
- •Subjects requiring systemic treatment with corticosteroids (\> 10 mg/day prednisone or equivalent) or other immunosuppressive agents were given the study drug within 14 days prior to administration. Inhaled or topical corticosteroids and adrenaline replacement at a therapeutic dose of more than 10 mg/day prednisone are allowed in the absence of active autoimmune disease
- •Recieved anti-tumor vaccines or other anti-tumor therapy with immune stimulation within 3 months.
- •Prior exposure to any PD-1/PD-L1/PD -L 2 or CTLA -4 antibody .
- •Participating in other clinical studies or less than 4 weeks before the end of a clinical trial;
- •Known and suspicion of interstitial pneumonia
Arms & Interventions
SHR1210 +Apatinib
SHR-1210 injection, 200 mg/dose, intravenous infusion within 20-60 minutes.
Intervention: SHR1210
Outcomes
Primary Outcomes
objective response rate
Time Frame: from first patient first visit to 6 month after last patient first visit
rate of subjects achieved complete response plus partial response in all evaluable subjects