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

NCT ID: NCT04366128

Last Updated: 2021-09-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-25
• Study Completion Date: 2023-12-30

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CAPA indution immunotherapy

CAPA regimen, repeat every 3 week for 4 cycles.

Group Type: EXPERIMENTAL

CAPA indution immunotherapy

Intervention Type: 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.

Interventions

CAPA indution immunotherapy

1. Camelirumab 200mg Intravenous injection on day 1.

2. Apatinib 250mg taken orally once daily.

3. Pegaspargase 2000U/m2 Intramuscular injection on day 1.

Intervention Type: DRUG

Other Intervention Names

Radiotherapy

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rong Tao

OTHER

Sponsor Role: lead

Responsible Party

Rong Tao

Associate director of department of hematology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Rong Tao, MD

Role: PRINCIPAL_INVESTIGATOR

Xinhua Hospital, Shanghai Jiaotong University School of Medicine

Locations

Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Shanghai Eye Ear Nose and Throat Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Department of Hematology, Xinhua hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Rong Tao, MD

Role: CONTACT

hkutao@hotmail.com

008621-25077603

Chuanxu Liu, MD

Role: CONTACT

liuchuanxu@xinhuamed.com.cn

008621-25077607

Facility Contacts

Zhiming Li, MD

Role: primary

lizhm@sysucc.org.cn

0086-020-87343765

Hao Ding, MD

Role: primary

eentding@163.com

+86-21-64377134

Chuanxu Li, MD

Role: primary

liuchuanxu@xinhuamed.com.cn

008621-25077607

Other Identifiers

XHLSG-NK-1902

Identifier Type: -

Identifier Source: org_study_id