Association of Inflammatory Markers (ICC, MCVL) With Anti PD-1 Antibody Nivolumab Response: Evaluating Biomarkers for Predicting Immunotherapy Success in Patients With Metastatic Renal Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Progression-Free Survival
研究概览
简要总结
This study is an observational study aimed at investigating the potential of new inflammatory markers to predict treatment response in patients with metastatic renal cell carcinoma (mRCC) undergoing anti-PD-1 antibody nivolumab therapy. Specifically, the study focuses on evaluating how well the Cumulative Inflammatory Index (ICC) and Mean Corpuscular Volume/Lymphocyte Ratio (MCVL) can predict the response to nivolumab treatment and the progression of the disease.
The participant group consists of patients aged 18 and older who have been diagnosed with metastatic renal cell carcinoma. Inflammatory markers were monitored at regular intervals throughout the treatment period.
The primary endpoints of the study are as follows:
- Progression-Free Survival (PFS): To determine how long nivolumab treatment can halt disease progression.
- Overall Survival (OS): To assess the overall survival of participants following treatment.
- Disease Control Rate (DCR): To evaluate the disease control rates (stable disease, partial response, complete response) at 3, 6, and 12 months of Nivolumab treatment.
This study aims to deeply analyze the impact of inflammatory markers such as ICC and MCVL on disease progression and treatment response, determining to what extent these markers serve as predictors of treatment success. Additionally, it explores how these markers can be utilized in personalized treatment strategies to improve therapeutic outcomes.
详细描述
This observational study investigates the potential of new inflammatory markers to predict treatment response in patients with metastatic renal cell carcinoma (mRCC) undergoing anti-PD-1 antibody nivolumab therapy. The study specifically aims to evaluate how well the Cumulative Inflammatory Index (ICC) and Mean Corpuscular Volume/Lymphocyte Ratio (MCVL) can predict the response to nivolumab treatment and the progression of the disease.
Detailed Characteristics of the Participants:
Age Range: The participants cover a wide age range, from young adults to elderly individuals.
Gender and General Health Status: The gender of the participants is not specified, but all participants are adults diagnosed with metastatic renal cell carcinoma. Most have previously undergone treatment for renal cancer, and their disease has metastasized.
Histological Subtypes: The majority of participants have clear cell renal cell carcinoma (clear cell RCC). Other histological subtypes, including papillary, chromophobe, and sarcomatoid types, are also represented.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 19 Years 至 87 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: Participants must be ≥18 and ≤87 years old. Diagnosis: Patients must have been diagnosed with metastatic renal cell carcinoma (mRCC).
- •Treatment: Only patients receiving nivolumab treatment for metastatic renal cell carcinoma are included.
- •Consent: Written informed consent was obtained from all participants
排除标准
- •Other Active Cancers: Patients with concurrent active malignancies were excluded from the study.
- •Prior Immunotherapy Treatment: Patients who had previously received any form of immunotherapy (anti-PD-1, anti-PD-L1, or similar immunological agents) were excluded.
- •Uncontrolled Systemic Diseases: Patients with severe, uncontrolled systemic diseases (e.g., significant cardiovascular, pulmonary, or liver diseases) were not included in the study.
- •Active Infections: Patients with serious active infections, such as active tuberculosis, HIV infection, or chronic hepatitis B or C, were excluded.
- •Pregnancy and Breastfeeding: Pregnant or breastfeeding women were not eligible for inclusion in the study.
- •Immunodeficiency or Immunosuppressive Therapy: Patients with immunodeficiency or those receiving immunosuppressive therapy (e.g., corticosteroids) were excluded from the study.
结局指标
主要结局
Progression-Free Survival
时间窗: 12th Month
Progression-free survival (PFS) was assessed to determine if the disease had progressed, using disease control rates as a reference.
Disease Control Rate (DCR)
时间窗: 12th month
The disease control rate (DCR) was evaluated to assess the response to treatment, including the rates of stable disease, partial response, and complete response.
Overall Survival
时间窗: 12th month
Overall Survival (OS) was assessed to evaluate the survival status of the patients following treatment initiation.
次要结局
- Changes in Inflammatory Markers (ICC)(12th month)
- Changes in Inflammatory Markers (MCVL)(12th month)
- Immune-related adverse events (irAEs)(12th month)
- Response Based on Metastatic Sites(12th month)
- Evaluation of Neutrophil-Lymphocyte Ratio(12th month)
- Evaluation of Platelet-Lymphocyte Ratio(12th month)
研究者
Heves Sürmeli
Consultant
Dr. Lutfi Kirdar Kartal Training and Research Hospital