NCT07574528尚未招募2 期
A Multicenter, Single-Arm, Phase II Study of Sintilimab, Pegaspargase and Selinexor Followed by Radiotherapy in Newly Diagnosed Stage I/II Extranodal NK/T-Cell Lymphoma
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2026年5月6日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 47
- 试验地点
- 1
研究概览
简要总结
This is a single-arm, open-label, multicenter phase II study evaluating sintilimab, pegaspargase, and selinexor followed by radiotherapy as first-line treatment for patients with newly diagnosed stage I/II extranodal natural killer/T-cell lymphoma (ENKTL).
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older.
- •No prior systemic treatment for lymphoma, except short-term corticosteroids for symptom control.
- •Life expectancy of more than 3 months.
- •Eastern Cooperative Oncology Group performance status of 0 to
- •Histologically confirmed extranodal natural killer/T-cell lymphoma.
- •Primary lesion located in the nasal cavity or upper aerodigestive tract.
- •Stage I to II disease.
- •At least one measurable or evaluable lesion according to Lugano 2014 criteria.
- •Adequate organ and bone marrow function.
排除标准
- •Aggressive NK-cell leukemia.
- •Significant dysfunction of major organs.
- •Known hypersensitivity to any study drug or its components, or contraindication to any study treatment.
- •Pregnant or breastfeeding women, or participants of childbearing potential unwilling to use effective contraception.
- •Known history of human immunodeficiency virus infection or acquired immunodeficiency syndrome.
研究者
Qingqing Cai
Professor and Chief Physician
Sun Yat-sen University
研究点 (1)
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