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

NCT07012174 | Completed DMC

• 2 other identifiers: No.G2023-176-0182373431, 82202947, 82473395,
• Study Type: observational
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Colo-rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival

  Time from initiation of anti-PD-1 therapy to documented disease progression or death from any cause, whichever occurs first.

  Up to 36 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥18 years old) with histologically confirmed colorectal adenocarcinoma who received at least two cycles of anti-PD-1 immune checkpoint inhibitor therapy at Sun Yat-sen University Cancer Center between January 2019 and December 2022. All participants had available baseline BMI and lipid profile data. The cohort includes both males and females, with a mix of MSI-H and MSS cases, across various disease stages.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Peirong Ding

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Colorectal Surgery

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 10, 2025
• Study Start: January 1, 2019
• Primary Completion: December 31, 2022
• Study Completion: April 30, 2025
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)