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A Study of Tislelizumab, Chemotherapy, and Radiation Therapy for Early-Stage High-Risk ENKTCL (CLCG-2102)
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Summary
The current study is a phase II multi-center single arm trial to evaluate the efficacy and safety of inductive Anti-PD-1+P-GEMOX treatment followed by radiotherapy and concurrent Anti-PD-1 antibody in early-stage Intermediate/High-Risk extranodal NK/T cell lymphoma
Official title: Tislelizumab Plus Dose-Dense P-GemOx and Radiation Therapy for Early-Stage Intermediate/High-Risk Extranodal NK/T-Cell Lymphoma: A Multicenter Phase II Trial
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
54
Start Date
2021-11-10
Completion Date
2026-03-31
Last Updated
2026-08-18
Healthy Volunteers
No
Interventions
Anti-PD-1 monoclonal antibody
200mg iv on Day 1 of each 14-day cycle for 3 cycles in induction treatment; 200mg iv on Day 1,15, 29 during RT treatment
Pegaspargase
3000 IU im on Day 2 of each 14-day cycle for 3 cycles in induction treatment
Gemcitabine
1g/m2 iv on Day 2 of each 14-day cycle for 3 cycles in induction treatment
Oxaliplatin
85 mg/m2 iv on Day 2 of each 14-day cycle for 3 cycles in induction treatment
Involved site radiotherapy
Involved site radiotherapy according to the ILROG guideline with primary tumor dose of 50Gy 14-28 days after inductive therapy
Locations (1)
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China