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| Name | Class |
|---|---|
| Peking University Cancer Hospital & Institute | OTHER |
| The First Hospital of Jilin University | OTHER |
| Affiliated Cancer Hospital & Institute of Guangzhou Medical 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 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inductive and concurrent anti-PD-1 antibody combined with radiotherapy | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-PD-1 monoclonal antibody | Drug | inductive Anti-PD-1 antibody + concurrent Anti-PD-1 antibody with RT |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers to predict anti-PD-1 antibody efficacy and 2y-PFS | potential biomarkers in baseline tumor samples and blood samples | baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shunan Qi, MD | Contact | +8610-87788995 | medata@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Ye-Xiong Li, MD | CAMS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Recruiting | Beijing | Beijing Municipality | 100021 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38018460 | Derived | Li JY, Qi SN, Hu C, Liu X, Yang Y, Wu T, Zheng R, Feng XL, Ni XG, Jin FY, Song YQ, Liu WP, Zhou SY, Li YX. Tislelizumab and radiation therapy in low-risk early-stage extranodal natural killer/T-cell lymphoma, nasal type: a phase II study protocol. Future Oncol. 2024 Feb;20(5):245-256. doi: 10.2217/fon-2023-0065. Epub 2023 Nov 29. |
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All IPD that underlie results in a publication
From: 6 months after publication. To: 5 years after publication
Will share data with the PIs who had specific study plan in immunotherapy area and biomarker area
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| 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 |
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| ID | Term |
|---|---|
| C000711728 | spartalizumab |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| 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 |
|
| D009369 |
| Neoplasms |