Body Mass Index and Lipid Metabolism in Relation to Anti-PD-1 Immunotherapy in Colorectal Cancer: A Retrospective Observational Study With Lipidomic Profiling
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Progression-Free Survival
研究概览
简要总结
This observational study aims to evaluate the impact of body mass index (BMI) and dyslipidemia on the effectiveness of anti-PD-1 immunotherapy in patients with colorectal cancer (CRC). A total of 142 patients treated with immune checkpoint inhibitors at Sun Yat-sen University Cancer Center were retrospectively analyzed. The study assessed progression-free survival (PFS) based on BMI and lipid profiles. Lipidomic profiling was also performed to explore potential metabolic mechanisms. The aim of this study was to identify simple, clinically applicable biomarkers to guide treatment decisions for CRC patients receiving immunotherapy.
详细描述
This retrospective observational study investigates the prognostic value of body mass index (BMI) and dyslipidemia in colorectal cancer (CRC) patients treated with anti-PD-1 immune checkpoint inhibitors (ICIs). A total of 142 patients were included, all of whom received at least two cycles of PD-1 inhibitors, including Camrelizumab, Nivolumab, Pembrolizumab, Sintilimab, Tislelizumab, or Toripalimab, at Sun Yat-sen University Cancer Center between January 1, 2019, and December 31, 2022.
The primary objective of the study was to evaluate progression-free survival (PFS) stratified by BMI and lipid profile status. Patients were grouped by BMI into normal (<24 kg/m²) and overweight (≥24 kg/m²) categories, based on WHO standards for the Chinese population. Dyslipidemia was defined according to standard lipid thresholds. Kaplan-Meier and Cox proportional hazard models were used for survival analysis. Additionally, a subset of 12 patients underwent pre-treatment serum lipidomic profiling using ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) to explore potential metabolic mechanisms contributing to differential responses.
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
- •Age ≥ 18 years at time of diagnosis
- •Histologically confirmed colorectal adenocarcinoma
- •Received at least two doses of anti-PD-1 immune checkpoint inhibitor therapy (e.g., Camrelizumab, Nivolumab, Pembrolizumab, Sintilimab, Tislelizumab, or Toripalimab)
- •Availability of baseline body mass index (BMI) and lipid profile within 30 days prior to ICI initiation
- •Adequate clinical records for retrospective data collection
- •Signed informed consent for data usage (if applicable to retrospective cohort)
排除标准
- •Participation in another interventional clinical trial during the study period
- •Incomplete PD-1 treatment (< 2 cycles)
- •Severe immune-related adverse events leading to early discontinuation of immunotherapy
- •Missing or incomplete BMI or lipid profile data
- •Loss to follow-up prior to outcome assessment
结局指标
主要结局
Progression-Free Survival
时间窗: Up to 36 months
Time from initiation of anti-PD-1 therapy to documented disease progression or death from any cause, whichever occurs first.
次要结局
未报告次要终点
研究者
Pei-Rong Ding
Director of the Department of Colorectal Surgery
Sun Yat-sen University