Camrelizumab Pegaspargase and Apatinib With Radiation Therapy for Stage IE/IIE ENKTL

  • STATUS
    Recruiting
  • End date
    Dec 30, 2023
  • participants needed
    60
  • sponsor
    Rong Tao
Updated on 14 February 2021

Summary

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.

Description

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.

Details
Condition Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type, Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type, Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type, Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type
Treatment CAPA indution immunotherapy
Clinical Study IdentifierNCT04366128
SponsorRong Tao
Last Modified on14 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 80 yrs?
Gender: Male or Female
Do you have Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type?
Do you have any of these conditions: Do you have Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type??
Do you have any of these conditions: Do you have Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type??
Do you have any of these conditions: Do you have Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type??
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
Blood routine test: neutrophil count1.0 10^9/L, Hemoglobin80g/L, Platelet50 10^9/L
Coagulation routine: plasma fibrinogen 1.0g / L
Liver function: Alanine aminotransferase, aspartate aminotransferase and total bilirubin 2 times the upper limit of normal value
Renal function: Creatinine is normal
Refers to oxygen saturation> 93%
Cardiac function: Left ventricular ejection fraction 50%, electrocardiogram does not suggest any acute myocardial infarction, arrhythmia or atrioventricular block above 1 degree
Signed informed consent
Voluntarily follow the research protocol, follow-up plan, laboratory and auxiliary examinations

Exclusion Criteria

accompanied with HCV or HIV infection, HBV-infected patients who also receive antiviral treatment are not excluded
Severe infection requires ICU treatment
Serious complications such as hemophagocytic syndrome, DIC, etc
Impairment of important organ functions: such as respiratory failure, chronic congestive heart failure with NYHA grade 3, decompensated liver or kidney dysfunction, hypertension and diabetes that cannot be controlled despite active treatment
Have a history of autoimmune diseases, have disease activity in the last 6 months, and are still taking oral immunosuppressive therapy within the past three months, with a daily dose of oral prednisone greater than 10 mg
Pregnant and lactating women
Those who are known to be allergic to drugs in the CAPA regimen
Patients with other tumors who need surgery or chemotherapy within 6 months
Other experimental drugs are being used
The investigators believe that other clinical conditions (including medical history or the presence of comorbidities) of the patient will significantly increase the risk of the subject when using the study treatment drugs
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