Clinical trial NCT04366128: Camrelizumab, Pegaspargase and Apatinib With Radiation Therapy for Stage IE/IIE ENKTL
Official title: Camrelizumab, Pegaspargase and Apatinib With Radiation Therapy for Stage IE/IIE Natural Killer /T-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type
Keywords: camrelizumab
apatinib
pegaspargase
radiotherapy
natural killer/T-cell lymphoma
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Camrelizumab, apatinib and pegaspargase
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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:

  1. Blood routine test: neutrophil count≥1.0 × 10\^9/L, Hemoglobin≥80g/L, Platelet≥50 × 10\^9/L.
  2. Coagulation routine: plasma fibrinogen ≥ 1.0g / L.
  3. Liver function: Alanine aminotransferase, aspartate aminotransferase and total bilirubin ≤ 2 times the upper limit of normal value.
  4. Renal function: Creatinine is normal.
  5. Refers to oxygen saturation\> 93%.
  6. 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.

Primary outcomes:
measure: Rate of complete response at week 24
timeFrame: 24 weeks
Secondary outcomes:
measure: Rate of overall response rate at week 24
timeFrame: 24 weeks
measure: Rate of overall survival at 2 years
timeFrame: 2 years
measure: Rate of progression free survival at 2 years
timeFrame: 2 years
measure: percent of adverse events
timeFrame: 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University
state: Guangdong
city: Shanghai
country: China
facility: Shanghai Eye Ear Nose and Throat Hospital, Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Department of Hematology, Xinhua hospital
state: Shanghai
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiaotong University School of Medicine
name: Rong Tao, MD
role: PRINCIPAL_INVESTIGATOR
References: