NCT07012174

Impact of Body Mass Index and Lipid Metabolism on Anti-PD-1 Immunotherapy Outcomes in Colorectal Cancer

Body Mass Index and Lipid Metabolism in Relation to Anti-PD-1 Immunotherapy in Colorectal Cancer: A Retrospective Observational Study With Lipidomic Profiling

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 142 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Colo-rectal Cancer

Timeline

• Start date: 2019-01-01
• Primary completion: 2022-12-31
• Completion: 2025-04-30
• First posted: 2025-06-10
• Last updated: 2025-06-10

Locations

1 site across 1 country: China