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Brief Title: PD-1 Antibody SHR-1210 in Patients With Relapsed or Refractory Classic Hodgkin's Lymphoma
Official Title: An Open-Label, Single Arm, Multi-Center, Phase 2 Study of PD-1 Antibody SHR-1210 in Subjects With Relapsed or Refractory Classic Hodgkin's Lymphoma
Study ID: NCT03155425
Brief Summary: This is an open-label, multicenter, non-randomized, phase 2 trial to evaluate efficacy and safety of SHR-1210 in patients with relapsed or refractory classic Hodgkin's lymphoma. The primary objective is to assess ORR of SHR-1210 in patients with relapsed or refractory classic Hodgkin's lymphoma.
Detailed Description: The primary objective of this phase 2 study is to assess objective response rate of SHR-1210 in patients with relapsed or refractory classic Hodgkin's lymphoma. The secondary objective is to observe the duration of response, progression free survival, time to response, overall survival and safety of SHR-1210 in relapsed or refractory classic Hodgkin's lymphoma. Pharmacokinetic index is also investigated in 12 patients.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Beijing Cancer Hospital, Beijing, Beijing, China
Jiangsu Cancer Hospital, Nanjing, Jiangsu, China
Name: Zhenyu Xiao, MD
Affiliation: Jiangsu Hengrui Pharmaceuticals Co.,Ltd
Role: STUDY_DIRECTOR