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The purpose of this study is to evaluate the efficacy and safety of camrelizumab, apatinib, pegaspargase (CAPA) and as an intruction immunotherapy with radiotherapy as first-line treatment in patients with de novo stage IE/IIE extranodal natural killer/T-cell lymphoma, nasal type.
Extranodal natural killer/T-cell lymphoma (ENKTCL), nasal type, is a rare subtype of non-Hodgkin lymphoma (NHL) with relatively high incidence in China. Radiotherapy alone for stage IE/IIE diseases has good response rate but with high relapse rates, ranging from 20-50%. The combination of chemotherapy and radiotherapy improved the long-term survival for patients with stage IE/IIE diseases. But the optimal treatment schedule has not been established. This study is designed with four cycles CAPA induction immunotherapy, followed by 50-56Gy radiotherapy as an approach for stage IE/IIE ENKTCL. The efficacy and safety of this treatment will be measured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAPA indution immunotherapy | Experimental | CAPA regimen, repeat every 3 week for 4 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAPA indution immunotherapy | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of complete response at week 24 | Rate of patients with complete response (CR) at week 24 evaluate by Lugano 2014 criteria | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of overall response rate at week 24 | Rate of patients with complete response and partial response (ORR) at week 24 evaluate by Lugano 2014 criteria | 24 weeks |
| Rate of overall survival at 2 years |
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Inclusion Criteria:
Patients who meet the WHO 2016 diagnostic criteria for NK/T-cell lymphoma by biopsy histopathology, immunohistochemistry and EBER.
The primary site is in the nasal cavity or upper gastrointestinal tract. The de novo diagnosed patient has at least one objective and evaluable lesion.
Stage IE / IIE disease according to Lugano 2014 lymphoma staging system.
ECOG score 0-3.
The laboratory examination within 1 week before entering the group meets the following conditions:
Signed informed consent.
Voluntarily follow the research protocol, follow-up plan, laboratory and auxiliary examinations.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rong Tao, MD | Contact | 008621-25077603 | hkutao@hotmail.com | |
| Chuanxu Liu, MD | Contact | 008621-25077607 | liuchuanxu@xinhuamed.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Rong Tao, MD | Xinhua Hospital, Shanghai Jiaotong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Camrelizumab, apatinib and pegaspargase
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Camrelizumab, apatinib and pegaspargase indution immunotherapy
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|
overall survival rate (OS) of patients at 2 years
| 2 years |
| Rate of progression free survival at 2 years | progression free survival rate (PFS) of patients at 2 years | 2 years |
| percent of adverse events | adverse events graded by NCI CTCAE Ver4.03 | 2 years |
| Shanghai Eye Ear Nose and Throat Hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
|
| Department of Hematology, Xinhua hospital | Recruiting | Shanghai | Shanghai Municipality | 200092 | China |
|