ICK-Gyn: Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Prognostic value of CRP kinetics under ICI therapy on progression-free survival (PFS)
研究概览
简要总结
ICK-Gyn is a prospective, multicentric, non-interventional investigator-initiated trial (IIT) that aims to investigate the prognostic value of CRP kinetics in advanced or metastatic gynecological malignancies under immune checkpoint inhibitor (ICI) therapy on the objective response rate (ORR), progression-free survival (PFS) and overall survival (OS).
详细描述
Immunotherapy, which involves activating the body's immune system for cancer treatment, has already been widely incorporated into the standard care of patients with advanced and metastatic gynecological cancers.
This study aims to investigate how inflammatory markers such as C-reactive protein (CRP) change during and after immunotherapy. Study findings from other tumor types (kidney, lung, bladder) suggest that immunotherapy is particularly effective when a mild inflammatory response is triggered in the body. The investigators want to examine this using CRP measurement. CRP measurement can easily be integrated into clinical routine as it only requires a blood sample.
The goal of this prospective study is to determine whether changes in CRP levels in the blood can predict the disease progression or response to immunotherapy.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •women ≥ 18 years of age
- •histologically proven metastatic gynecological malignancies irrespective of therapy line
- •patients with advanced or metastatic gynecological malignancies must fulfill treatment requirements for ICI therapy in the experimental group
- •planned ICI therapy in combination with palliative chemotherapy in the experimental group
- •patients with advanced or metastatic gynecological malignancies that undergo chemotherapy without ICIs in the first therapy line in the control group
- •written informed consent into ICK-Gyn
排除标准
- •missing indication for ICI therapy in the experimental group
- •any ICI therapy before inclusion into the trial
- •patients with advanced or metastatic endometrial or cervical cancer in the second or higher therapy line without indication to ICI therapy
- •pregnant or lactating patients
- •inadequate general condition (not fit for chemotherapy)
研究组 & 干预措施
Control Group
Chemotherapy without immunotherapy
Experimental Group
Chemotherapy in combination with immunotherapy
结局指标
主要结局
Prognostic value of CRP kinetics under ICI therapy on progression-free survival (PFS)
时间窗: duration of therapy and follow-up data (10 years)
Evaluation of CRP kinetics to predict progression-free survival in advanced or metastatic gynecological malignancies treated with ICIs in combination with chemotherapy. The CRP value is determined from blood samples.
次要结局
- Prognostic value of CRP kinetics in advanced or metastatic gynecological malignancies under ICI therapy on the objective response rate (ORR) and overall survival (OS).(duration of therapy and follow-up data (10 years))