A Multicenter, Phase 2, Randomized Trial of Sintilimab (PD-1 Antibody) With P-GEMOX Versus the P-GEMOX Regimen in the Teatment of Newly Diagnosed Advanced-stage Extranodal Natural Killer/T Cell Lymphoma (ENKTL) (SPIRIT-02)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
Extranodal NK/T-cell lymphoma is a rare and highly aggressive subtype of non-Hodgkin lymphoma. While the overall survival rates have improved for early-stage ENKTL patients, the prognosis for those with advanced disease remains poor, and there is currently no standard treatment. PD-1/PD-L1 inhibitors have demonstrated significant efficacy in various cancers, and recent studies have shown promising results in extranodal NK/T-cell lymphoma as well. Although PD-1 antibodies have exhibited efficacy in relapsed or refractory patients, their effectiveness when combined with chemotherapy as a first-line treatment remains unclear. This study aims to evaluate the efficacy and safety of sintilimab combined with chemotherapy in a randomized controlled trial for newly diagnosed advanced extranodal NK/T-cell lymphoma patients, while also exploring potential biomarkers that may predict treatment outcomes, offering new therapeutic options for extranodal NK/T-cell lymphoma patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Pathologically diagnosed with ENKTL.
- •Advanced stage.
- •Has at least one measurable or assessable lesion.
- •Age > 18 years, no gender restrictions, with an expected survival of more than 3 months.
- •Willing to participate in the clinical study; fully informed and has signed a written informed consent form.
- •Adequate organ and bone marrow function.
排除标准
- •Aggressive NK-cell leukemia.
- •Central nervous system involvement.
- •Patients with significant dysfunction of vital organs.
- •History of allergy to the investigational drug, similar drugs, or excipients.
- •Less than 6 weeks since major organ surgery (excluding surgery for biopsy purposes).
- •Pregnant or breastfeeding women, and women of childbearing potential who are unwilling to use contraception.
- •Active infection, excluding fever related to tumor-associated B symptoms.
- •Known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome (AIDS).
研究组 & 干预措施
control group
P-GEMOX Regimen
干预措施: P-GEMOX Regimen (Drug)
experimental group
Sintilimab with P-GEMOX Regimen
干预措施: Sintilimab with P-GEMOX Regimen (Drug)
结局指标
主要结局
PFS
时间窗: Up to 4 years
progression free survival
次要结局
- ORR rate(Up to 4 years)
- CR rate(Up to 4 years)
- OS(Up to 4 years)
- Adverse events(Up to 4 years)
研究者
Qingqing Cai
Professor
Sun Yat-sen University