NCT03701022

PD1 Combined With Apatinib in Patients With Relapsed or Refractory NK/T Cell Lymphoma

An Open-lable, Single Arm, Single Center, Phase 2 Study of PD1 Combined With Apatinib in Patients With Relapsed or Refractory NK/T Cell

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• NK/T-cell Lymphoma

Interventions

Type	Name	Description
DRUG	SHR1210	SHR-1210 injection, 200 mg/dose, intravenous infusion within 20-60 minutes. Apatinib oral administration, 500mg per day.

Timeline

• Start date: 2018-10-20
• Primary completion: 2020-03-30
• Completion: 2021-06-30
• First posted: 2018-10-09
• Last updated: 2018-10-09