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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Enrolling; Phase 2

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

Treatments: Drug: Anti-PD-1 monoclonal antibody

Study type: Interventional

Funder types: Other

Identifiers

NCT05149170

CLCG-NKT-2101

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Inductive and concurrent anti-PD-1 antibody combined with radiotherapy

Experimental group

Description:

All the enrolled patients receive 2 doses of inductive anti-PD-1 antibody (Tislelizumab 200mg) every two weeks, and then Involved-site radiotherapy (50±6-10 Gy) with concurrent anti-PD-1 antibody (Tislelizumab 200mg) every two weeks.

Treatment:

Drug: Anti-PD-1 monoclonal antibody