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| Name | Class |
|---|---|
| Peking University Cancer Hospital & Institute | OTHER |
| The Affiliated Hospital Of Guizhou Medical University | OTHER |
| The First Hospital of Jilin University | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inductive and concurrent anti-PD-1 antibody combined with chemo-radiotherapy | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-PD-1 monoclonal antibody | Drug | 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 |
|
| 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) |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| biomarkers (single cell transcriptomics) | baseline, 2 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shunan M Qi | Contact | +861087788995 | medata@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Shunan M Qi, MD | Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Recruiting | Beijing | Beijing Municipality | 100021 | China |
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|
| Pegaspargase | Drug | 3000 U/m2 im on Day 2 of each 14-day cycle for 3 cycles in induction treatment |
|
| Gemcitabine | Drug | 1g/m2 iv on Day 2 of each 14-day cycle for 3 cycles in induction treatment |
|
| Oxaliplatin | Drug | 1g/m2 iv on Day 2 of each 14-day cycle for 3 cycles in induction treatment |
|
| Involved site radiotherapy | Radiation | Involved site radiotherapy according to the ILROG guideline with primary tumor dose of 50-56Gy 14-28 days after inductive therapy |
|
| 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 |
| ID | Term |
|---|---|
| D054391 | Lymphoma, Extranodal NK-T-Cell |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000711728 | spartalizumab |
| C000707970 | tislelizumab |
| C042705 | pegaspargase |
| D000093542 | Gemcitabine |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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