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

Study Overview
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Brief Summary
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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

Official Title
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Radiotherapy With Inductive and Concurrent Anti-PD-1 Antibody in Early-stage Low-risk Extranodal NK/T Cell Lymphoma, Nasal Type: A Multi-center Phase II Study

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

Intervention / Treatment
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* Drug: Anti-PD-1 monoclonal antibody


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inductive and concurrent anti-PD-1 antibody combined with radiotherapy<br>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. | Drug: Anti-PD-1 monoclonal antibody<br>* inductive Anti-PD-1 antibody + concurrent Anti-PD-1 antibody with RT<br>* Other names: radiotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Complete response after inductive therapy | complete resolution of disease in imaging and biopsy after inductive therapy | 2-4 weeks after inductive anti-PD-1 antibody | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival rate at year 2 after enrollment, 2y-PFS | From enrollment to any disease progression or death | 2-year | 
| Overall Survival rate at year 2/5 after enrollment，2y-/5y-OS | From enrollment to death | 2-year, 5-year | 
| Rate of acute toxicity (any and above grade 3) | toxicities according to CTCAE criteria | From enrollment to 3 months after treatment | 
| Quality of Life change, QoL | measurement basing on EORTC-QLQ-HN35 tables | baseline, 1/3/6/12/24 months after treatment | 
| Quality of Life change, QoL | measurement basing on EORTC-QLQ-C30 tables | baseline, 1/3/6/12/24 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NK/T-Cell Lymphoma, Nasal and Nasal-Type, radiotherapy, Anti-PD-1 Antibody