A Study on the Efficacy and Safety of Tislelizumab in Combination With Gemcitabine and Sequential Pemetrexed Radiotherapy for Patients With Primary Stage I-II NK/T-Cell Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
In the past 10 years, there have been many effective explorations on the treatment of NK/TCL at home and abroad, which has innovated the treatment mode. Since ENKTCL-NT cells are sensitive to radiotherapy, radiotherapy is considered to be the most reliable treatment for ENKTCL-NT. Although patients with radiotherapy alone have excellent short-term efficacy and can achieve CR in 70-97% of patients, the 5-year PFS is only 30.5-61%, with a higher recurrence rate 5,6. The combination of chemotherapy and radiotherapy significantly improved the survival of patients compared with historical controls. Recent studies have shown that the advantage of radiotherapy combined with chemotherapy is that it can significantly reduce the later recurrence of patients with radiotherapy alone. However, the traditional synchronous chemotherapy and radiotherapy have many and serious adverse reactions and poor tolerance in patients, so it cannot be widely applied.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of NK/T cell lymphoma .
- •Stage I/II patients .
- •ECOG score 0-2 points.
- •Sign informed consent.
- •Voluntary compliance with research protocols, follow-up plans, laboratory and auxiliary examinations.
排除标准
- •Patients with HCV or HIV infection and HBV infection receiving antiviral therapy at the same time are not excluded.
- •Complicated with severe infection requires ICU treatment.
- •There are serious complications such as hemophagic syndrome, DIC, etc.
- •Functional impairment of major organs.
- •A history of autoimmune disease.
- •Pregnant or lactating women.
- •Patients with a history of psychotropic drug abuse who cannot abstain or have mental disorders.
- •Patients who are known to be allergic to drugs used in chemotherapy regimens.
- •Patients with other tumors requiring surgery or chemotherapy within 6 months.
- •Patients who have participated in other clinical trials within 4 weeks prior to the trial;
- •Patients who are taking other investigational drugs.
- •Patients with severe allergic history or allergic constitution.
- •The target lesion has received radiation therapy or surgery (except biopsy);
- •Previously used chemotherapy, immunotherapy or biological targeted therapy for the primary tumor.
结局指标
主要结局
ORR
时间窗: At 14 weeks after treatment initiation
Objective Response Rate; The proportion of patients who achieved pre-specified tumor volume reduction and maintained the minimum time frame required by accepted response evaluation criteria, such as Solid Tumor RECIST Version 1.1.
次要结局
- PFS(up to 5 year)