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Radiotherapy and Anti-PD-1 in Low-risk ES-ENKTCL

Recruiting
18 - 70 years of age
Both
Phase 2

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Overview

The current study is a phase II multi-center single arm trial to evaluate the efficacy and safety of adding Anti-PD-1 antibody in an inductive and concurrent way to radiotherapy in early-stage low-risk extranodal NK/T cell lymphoma, nasal type

Eligibility

Inclusion Criteria:

  • Biopsy proved extranodal NK/T cell lymphoma
  • No previous anti-cancer treatment
  • Measurable lesion on baseline PET/CT and MRI
  • Stage I
  • Normal serum LDH level
  • Primary tumor invasion (PTI) absence
  • 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

Study details

Early-stage, Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type

NCT05149170

Chinese Academy of Medical Sciences

26 January 2024

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