Anti-PD-1 Antibody and P-GEMOX Chemotherapy Combined With Radiotherapy in High-risk Early-Stage ENKTL

• Status: Recruiting
• Trial end date: 2024-09-30
• Target enrollment: 0
• Participant gender: All

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 high-risk extranodal NK/T cell lymphoma, nasal type

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences
• Collaborators: Beijing Cancer Hospital; First Affiliated Hospital of Jilin University; The Affiliated Hospital Of Guizhou Medical University
• Treatments: Antibodies; Antibodies, Monoclonal; Gemcitabine; Oxaliplatin; Pegaspargase

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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