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

NCT04366128 | Unknown

• 1 other identifier: XHLSG-NK-1902
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type

Keywords

camrelizumab; apatinib; pegaspargase; radiotherapy; natural killer/T-cell lymphoma

Outcome Measures

Primary Outcomes (1)

• Rate of complete response at week 24

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

  24 weeks

Secondary Outcomes (4)

• Rate of overall response rate at week 24

  24 weeks

• Rate of overall survival at 2 years

  2 years

• Rate of progression free survival at 2 years

  2 years

• percent of adverse events

  2 years

Study Arms (1)

CAPA indution immunotherapy

EXPERIMENTAL

CAPA regimen, repeat every 3 week for 4 cycles.

Drug: CAPA indution immunotherapy

Interventions

CAPA indution immunotherapy DRUG

1. Camelirumab 200mg Intravenous injection on day 1. 2. Apatinib 250mg taken orally once daily. 3. Pegaspargase 2000U/m2 Intramuscular injection on day 1.

Also known as: Radiotherapy

CAPA indution immunotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 count≥1.0 × 10\^9/L, Hemoglobin≥80g/L, Platelet≥50 × 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rong Tao: lead

Study Sites (3)

Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

Shanghai Eye Ear Nose and Throat Hospital, Fudan University

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Department of Hematology, Xinhua hospital

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

MeSH Terms

Interventions

Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Rong Tao, MD

  Xinhua Hospital, Shanghai Jiaotong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rong Tao, MD

CONTACT

008621-25077603; hkutao@hotmail.com

Chuanxu Liu, MD

CONTACT

008621-25077607; liuchuanxu@xinhuamed.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Camrelizumab, apatinib and pegaspargase indution immunotherapy
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate director of department of hematology

Model Details: Camrelizumab, apatinib and pegaspargase

Study Record Dates

• First Submitted: April 25, 2020
• First Posted: April 28, 2020
• Study Start: April 25, 2020
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2023
• Last Updated: September 14, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)