Application of 18F-FDG PET/CT in Evaluating Treatment Response to Targeted Therapy Plus Immunotherapy in Patients With Metastatic Renal Cell Carcinoma: A Single-Center Retrospective Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- Treatment Response According to RECIST Version 1.1
研究概览
简要总结
This single-center retrospective observational study evaluates whether quantitative imaging features from pretreatment 18F-fluorodeoxyglucose positron emission tomography/computed tomography (18F-FDG PET/CT) can help predict response to first-line tyrosine kinase inhibitor (TKI) plus immune checkpoint inhibitor (ICI) therapy in patients with metastatic renal cell carcinoma.
The study reviews existing medical records and imaging data from 228 patients treated at the First Affiliated Hospital of Fujian Medical University between January 2019 and December 2025. Treatment was selected as part of routine clinical care and was not assigned by the study. Imaging features are extracted separately from the primary kidney tumor and metastatic lesions and are then combined to develop a patient-level multi-lesion radiomics model.
Treatment response is assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 approximately 12 weeks after treatment initiation. Complete response or partial response is classified as response, whereas stable disease or progressive disease is classified as non-response. The study compares imaging-based, clinical, and combined prediction models and also evaluates their association with progression-free survival.
详细描述
Patients with metastatic renal cell carcinoma may have different responses to first-line treatment combining a tyrosine kinase inhibitor with an immune checkpoint inhibitor. Differences may also occur among the primary renal tumor and metastatic lesions within the same patient. Pretreatment 18F-FDG PET/CT provides whole-body information about tumor glucose metabolism, while radiomics can extract quantitative imaging features that may reflect tumor heterogeneity.
This is a single-center retrospective observational cohort study using existing clinical, pathological, treatment, follow-up, and pretreatment 18F-FDG PET/CT data. Eligible patients had pathologically confirmed metastatic renal cell carcinoma, underwent 18F-FDG PET/CT before starting first-line TKI plus ICI therapy, had at least one measurable lesion according to RECIST version 1.1, and had adequate treatment-response and follow-up information. The study did not assign treatment or alter routine clinical care.
Primary renal tumors and eligible metastatic lesions are segmented separately on pretreatment PET/CT images. Conventional metabolic parameters and radiomic features are extracted from each lesion. For patients with multiple metastatic lesions, lesion-level features are aggregated to generate patient-level variables. Primary-tumor, metastatic-lesion, and combined multi-lesion radiomics models are developed. Clinical and metabolic variables are also evaluated, and a combined prediction model is constructed. Patients are divided into training and internal validation cohorts for model development and evaluation.
The primary outcome is treatment response assessed approximately 12 weeks after treatment initiation according to RECIST version 1.1. Complete response and partial response are classified as responder status, while stable disease and progressive disease are classified as non-responder status. Progression-free survival is also evaluated to explore whether the prediction model is associated with longer-term treatment benefit.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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 confirmed metastatic renal cell carcinoma.
- •Pretreatment 18F-FDG PET/CT performed before initiation of first-line systemic therapy.
- •Receipt of first-line tyrosine kinase inhibitor plus immune checkpoint inhibitor combination therapy.
- •At least one measurable lesion according to RECIST version 1.
- •Available clinicopathological, imaging, treatment response, and follow-up data.
排除标准
- •Receipt of systemic anticancer therapy before the pretreatment 18F-FDG PET/CT examination.
- •An interval of more than 1 month between pretreatment PET/CT and initiation of first-line systemic therapy.
- •Unavailable treatment response assessment or follow-up data.
- •Incomplete key clinicopathological or imaging information.
- •PET/CT image quality inadequate for lesion segmentation or radiomics analysis.
研究组 & 干预措施
Metastatic Renal Cell Carcinoma Cohort
Patients with pathologically confirmed metastatic renal cell carcinoma who underwent pretreatment 18F-FDG PET/CT and received first-line axitinib plus either pembrolizumab or toripalimab as part of routine clinical care. Clinical, pathological, imaging, treatment response, and follow-up data were retrospectively collected. Treatment was not assigned by the study.
干预措施: Pretreatment 18F-FDG PET/CT (Diagnostic Test)
Metastatic Renal Cell Carcinoma Cohort
Patients with pathologically confirmed metastatic renal cell carcinoma who underwent pretreatment 18F-FDG PET/CT and received first-line axitinib plus either pembrolizumab or toripalimab as part of routine clinical care. Clinical, pathological, imaging, treatment response, and follow-up data were retrospectively collected. Treatment was not assigned by the study.
干预措施: Axitinib Plus Pembrolizumab or Toripalimab (Drug)
结局指标
主要结局
Treatment Response According to RECIST Version 1.1
时间窗: At 12 weeks after initiation of first-line TKI plus ICI therapy
Number and percentage of participants categorized as having complete response, partial response, stable disease, or progressive disease according to Response Evaluation Criteria in Solid Tumors version 1.1. Complete response and partial response are classified as responder status, while stable disease and progressive disease are classified as non-responder status.
次要结局
- Progression-Free Survival(From treatment initiation to radiologically confirmed disease progression, death, or last follow-up, assessed up to 24 months)
研究者
Ning Xu
Professor; Chief Physician
First Affiliated Hospital of Fujian Medical University