Status:
UNKNOWN
Anti-PD-1 Antibody and P-GEMOX Chemotherapy Combined With Radiotherapy in High-risk Early-Stage ENKTL
Lead Sponsor:
Chinese Academy of Medical Sciences
Collaborating Sponsors:
Peking University Cancer Hospital & Institute
The Affiliated Hospital Of Guizhou Medical University
Conditions:
Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type
Early-stage
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- Biopsy proved extranodal NK/T cell lymphoma
- No previous anti-cancer treatment
- Measurable lesion on baseline PET/CT and MRI
- Stage I-II
- Have at lest one following risk factor: Elevated serum LDH level; PTI+; stage II
- ECOG PS 0-1
- Sufficient organ functions
Exclusion
- Other mature T- or NK- lymphoma
- Hemophagocytic lymphohistiocytosis
- Primary CNS lymphoma or CNS-involved lymphoma
- History of malignancy except for cutaneous basal-/squamous- cell carcinoma or cervical carcinoma in situ 3 years prior to study treatment
Key Trial Info
Start Date :
October 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2024
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT05254899
Start Date
October 1 2021
End Date
September 30 2024
Last Update
February 24 2022
Active Locations (1)
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1
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China, 100021