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NCT07241403Completed

Chronic Inflammation, Plasma Proteins Signature, Survival Outcomes and Clinical Response, in Patients Receiving Bevacizumab Combined With Oxaliplatin-based Chemotherapy (Bev/OX) or Bevacizumab Combined With Irinotecan-based Chemotherapy (Bev/IRI)

The Role of Chronic Inflammation in Modulating Targeted Therapy Efficacy and Predicting Treatment Outcomes in Metastatic Colorectal Cancer

Source: ClinicalTrials.gov · Last updated 21 Nov 2025

Brief summary (registry, in English)

Cancer-derived inflammation attenuates the efficacy of adjuvant chemotherapy (CT) in postoperative or metastatic colorectal cancer (mCRC). However, its role in mCRC patients receiving first-line Bevacizumab combined with chemotherapy (Bev/CT) remains unknown. In this prospective observational study, three Bev/CT regimen cohorts (discovery cohort,n=249; Internal validation cohort: n=115; external validation cohort: n=159) and one CT regimen cohort (n=175) were enrolled. Overall survival served as the primary endpoint; clinical response and progression-free survival were secondary endpoints evaluated during follow-up. Investigators used the serum inflammation ratios to evaluate the association between systemic inflammation and clinical outcomes in Bev/CT- and CT-treated mCRC. Combined analysis of 12 cytokines (flow cytometry) and 92 immuno-oncology proteins (Olink) revealed Bev resistance mechanisms and prognosis-predictive biomarkers in Bev/CT treated patients.

Status (registry)
Completed
Study type
Observational
Enrollment
698 (actual)
First submitted
25 Jul 2025
Start date
1 Jan 2018
Primary completion date
30 Dec 2024
Lead sponsor
Second Affiliated Hospital of Nanchang University
NCT number
NCT07241403

What you commit to

  • Study type: Observational
  • Participants enrolled: 698
  • From 1 Jan 2018 to the primary completion date, 30 Dec 2024
  • 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

  • Bacterial or virus infection within one month before diagnosis;
  • Taken anti-inflammatory drugs or other forms of chemotherapy before their diagnosis;

Other illness

  • More than two types of malignancies;

Other

  • participants whose follow-up was interrupted three months ago without reaching any endpoint.

Who the study is looking for

  • Clinical diagnosis of mCRC;
  • Aged over 18 years;
  • Must be able to receive the further treatment in the hospital.

Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
The second hospital of Nanchang university
Coordinator of this site? Confirm its status
NanchangChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.