INVESTIGATING DETERMINANTS OF IMMUNOTHERAPY EFFICACY IN ENDOMETRIAL CANCER: A MULTIDIMENSIONAL APPROACH IN A UNIQUE POPULATION (iDEA PROJECT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 510
- 试验地点
- 1
- 主要终点
- Progression-Free Survival
研究概览
简要总结
In recent years, the introduction of immune checkpoint inhibitors (ICI) in combination with chemotherapy has significantly changed the management of advanced and recurrent Endometrial Cancer (EC).
Despite these advances, responses to immunotherapy remain heterogeneous. Not all patients with mismatch repair-deficient (dMMR) tumors derive durable benefit, while a subset of mismatch repair-proficient (pMMR) tumors may respond. In addition, ICI treatment is associated with relevant costs and immune-related toxicities, highlighting the need for improved patient selection. To date, no validated predictive biomarkers beyond mismatch repair (MMR) status are available, reflecting limited understanding of the biological mechanisms underlying sensitivity and resistance to immunotherapy in EC.
This study aims to assess and integrate molecular and epigenetic features to identify prognostic and predictive biomarkers of immunotherapy response in endometrial cancer, and to explore their functional relevance using patient-derived experimental models.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Histologically confirmed advanced or recurrent endometrial carcinoma or carcinosarcoma
- •No prior treatment with immune checkpoint inhibitors
- •Availability of paired fresh-frozen and FFPE tumor samples
- •Provision of written informed consent for participation in translational research
排除标准
- •Refusal or inability to provide informed consent by the patient or legal representative
- •Mesenchymal tumors or epithelial tumors of non-endometrial origin (e.g., ovarian cancer)
- •Active treatment with immunomodulatory agents at the time of sample collection (e.g., immunotherapy for autoimmune disease)
- •Known positivity for HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV)
结局指标
主要结局
Progression-Free Survival
时间窗: 2 years
Time from enrollment to first disease progression or death from any cause, whichever occurs first
Overall Survival
时间窗: 2 years
Time from enrollment to death from any cause
次要结局
未报告次要终点