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

Not Applicable

• Conditions: Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type
• Interventions: Drug: CAPA indution immunotherapy

• Registration Number: NCT04366128
• Lead Sponsor: Rong Tao

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.

Study Timeline

• Study Start: 2020-04-25
• Study First Submitted: 2020-04-25
• Study First Submitted QC: 2020-04-25
• Study First Posted: 2020-04-28
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-13
• Last Update Posted: 2021-09-14
• Primary Completion: 2021-12-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CAPA indution immunotherapy	CAPA indution immunotherapy	CAPA regimen, repeat every 3 week for 4 cycles.

Primary Outcome Measures

Name	Time	Method
Rate of complete response at week 24	24 weeks	Rate of patients with complete response (CR) at week 24 evaluate by Lugano 2014 criteria

Secondary Outcome Measures

Name	Time	Method
Rate of overall response rate at week 24	24 weeks	Rate of patients with complete response and partial response (ORR) at week 24 evaluate by Lugano 2014 criteria
Rate of overall survival at 2 years	2 years	overall survival rate (OS) of patients at 2 years
percent of adverse events	2 years	adverse events graded by NCI CTCAE Ver4.03
Rate of progression free survival at 2 years	2 years	progression free survival rate (PFS) of patients at 2 years

Trial Locations

Locations (3)

Shanghai Eye Ear Nose and Throat Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China

Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

Department of Hematology, Xinhua hospital; 🇨🇳 Shanghai, Shanghai, China