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

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 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

Official Title
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Anti-PD-1 Antibody and P-GEMOX Chemotherapy Combined With Radiotherapy in High-risk Early-Stage Extranodal NK/T Cell Lymphoma, Nasal Type: A Multi-center Phase II Study

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

Intervention / Treatment
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* Drug: Anti-PD-1 monoclonal antibody
* Drug: Pegaspargase
* Drug: Gemcitabine
* Drug: Oxaliplatin
* Radiation: Involved site radiotherapy


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-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

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 chemo-radiotherapy<br>All the enrolled patients receive 3 cycles of anti-PD-1 antibody (Tislelizumab 200mg d1) + P-GEMOX (Pegaspargase 3000u d2, Gemcitabine 1g/m2 d2, Oxaliplatin 85mg/m2 d2) systemic treatment every 14 days, followed by involved-site radiotherapy with concurrent anti-PD-1 antibody (Tislelizumab 200mg) every two weeks. | Drug: Anti-PD-1 monoclonal antibody<br>* 200mg iv on Day 1 of each 14-day cycle for 3 cycles in induction treatment; 200mg iv on Day 1,15, 29 during RT treatment<br>* Other names: Tislelizumab;Drug: Pegaspargase<br>* 3000 U/m2 im on Day 2 of each 14-day cycle for 3 cycles in induction treatment<br>Drug: Gemcitabine<br>* 1g/m2 iv on Day 2 of each 14-day cycle for 3 cycles in induction treatment<br>Drug: Oxaliplatin<br>* 1g/m2 iv on Day 2 of each 14-day cycle for 3 cycles in induction treatment<br>Radiation: Involved site radiotherapy<br>* Involved site radiotherapy according to the ILROG guideline with primary tumor dose of 50-56Gy 14-28 days after inductive therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Response rate after 3 cycles of Anti-PD-1 antibody and P-GEMOX therapy | To evaluate the complete response (CR) rate after 3 cycles of Anti-PD-1 antibody and P-GEMOX therapy according to Lyric 2016 criteria | At the end of Cycle 3 (each cycle is 14 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival rate at year 2 after enrollment, 2y-PFS | From enrollment to disease progression or any death | 2 year | 
| Overall Survival rate at year 2/5 after enrollment，2y-/5y-OS | From enrollment to death | 2-year, 5-year | 
| acute toxicity | evaluated according to the CTCAE criteria | From enrollment to 3 months after treatment | 
| Quality of Life，QoL | evaluated according to EORTC-QLQ-HN35 | baseline, 1/3/6/12/24 months after treatment | 
| Quality of Life，QoL | evaluated according to EORTC-QLQ-C30 | 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, anti-PD-1 antibody, radiotherapy, chemotherapy, Pegaspargase