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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07012174

Enrollment

142

Registered

2025-06-10

Start date

2019-01-01

Completion date

2025-04-30

Last updated

2025-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colo-rectal Cancer

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Progression-Free Survival	Up to 36 months	Time from initiation of anti-PD-1 therapy to documented disease progression or death from any cause, whichever occurs first.

Countries

China

Outcome results