NCT07012174Completed
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
Source: ClinicalTrials.gov · Last updated 10 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 142 (actual)
- First submitted
- 28 May 2025
- Start date
- 1 Jan 2019
- Primary completion date
- 31 Dec 2022
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Colorectal cancer
- NCT number
- NCT07012174
What you commit to
- Study type: Observational
- Participants enrolled: 142
- From 1 Jan 2019 to the primary completion date, 31 Dec 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Severe immune-related adverse events leading to early discontinuation of immunotherapy
- Loss to follow-up prior to outcome assessment
Other
- Participation in another interventional clinical trial during the study period
- Incomplete PD-1 treatment (\< 2 cycles)
- Missing or incomplete BMI or lipid profile data
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.