Predictive Role of Circulating Biomarkers Involved in Angiogenesis in Metastatic Kidney Cancer in the Era of New Therapeutic Associations: Immunotherapies, Anti-angiogenic
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Progression-free survival
研究概览
简要总结
This is a multicenter, exploratory, prospective study to identify angiogenesis and immune-related biomarkers predictive of progression free survival in patients with metastatic or advanced renal cell carcinoma treated by a combination of immunotherapy and antiangiogenic.
详细描述
Recently, the management of renal cell carcinoma has undergone major changes with the emergence of combined therapies associating tyrosine kinase inhibitors (TKI) and immune checkpoint inhibitors (ICI) as first line treatments. However, there are no criteria to guide the choice between the different combinations validated and or between ICI combinations. Angiogenesis and immunity are intimately linked and some markers related have could be interesting to predict the efficacy of these combinations. Angiogenesis and immunity are highly related. This link may lead to new biomarkers to be explored to predict the response to TKI + ICI therapy combinations. On this basis, the investigators propose to conduct an open-label exploratory, multicenter prospective trial to study the association between angiogenesis and immune markers and the effect of combined TKI+ICI treatments.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven advanced or metastatic renal carcinoma
- •treated in first line with an ICI-ICI or ITK-ICI combination (following current recommendations at inclusion)
排除标准
- •Previous systemic treatment for renal cell carcinoma
- •Other cancer developed in the last 5 years except local forms apparently healed as basal cell cancer.
- •Contraindication for ICI-ICI or TKI-ICI combinations recommended on 1st line
- •Refusal to participate in the study
- •No affiliation to a social security regime (beneficiary or entitled)
- •Vulnerable patients as defined by french law (Public Heath Code sections L1121 -5 to L1121-8) :
- •Major patient subjected to legal protection (guardianship, curatorship, protection of justice)
- •Pregnant or breastfeeding woman
结局指标
主要结局
Progression-free survival
时间窗: 24 months
Time from inclusion to progression documented by imaging and based on RECIST 1.1 and iRECIST criteria or patient death. The iRECIST criteria use the same methods of monitoring tumor lesions as the RECIST 1.1 criteria but a confirmation 4-6 weeks after suspicion of progression is required to confirm or rule out progression because patients undergoing immunotherapy may present pseudo-progressions.
次要结局
- Objective response rate(24 months)
- Response duration(24 months)