Camrelizumab, Pegaspargase and Apatinib With Radiation Therapy for Stage IE/IIE Natural Killer /T-cell Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 6
- 主要终点
- Rate of complete response at week 24
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Camrelizumab, apatinib and pegaspargase indution immunotherapy
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •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.
排除标准
- •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.
研究组 & 干预措施
CAPA indution immunotherapy
CAPA regimen, repeat every 3 week for 4 cycles.
干预措施: CAPA indution immunotherapy (Drug)
结局指标
主要结局
Rate of complete response at week 24
时间窗: 24 weeks
Rate of patients with complete response (CR) at week 24 evaluate by Lugano 2014 criteria
次要结局
- Rate of overall response rate at week 24(24 weeks)
- Rate of overall survival at 2 years(2 years)
- percent of adverse events(2 years)
- Rate of progression free survival at 2 years(2 years)
研究者
Rong Tao
Associate director of department of hematology
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine