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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Resistance; Bevacizimab; Inflamation

• Study Type: Observational
• Enrollment (Actual): 698

Contacts and Locations

Study Locations

• China
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • The second hospital of Nanchang university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

In this study, all enrolled patients received first-line CT or Bev/CT based on the decisions made by both patients and clinicians. The treatment regimens included: (1) oxaliplatin-based CT (FOLFOX/XELOX, OX), (2) irinotecan-based CT (FOLFIRI/ XELIRI, IRI), (3) Bev combined with oxaliplatin-based CT (Bev/OX), and (4) Bev combined with irinotecan-based CT (Bev/IRI). All the patients underwent at least two cycles of Bev/CT until they either withdrew from the disease, experienced disease progression, or encountered intolerable toxic effects.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• More than two types of malignancies;
• Bacterial or virus infection within one month before diagnosis;
• Taken anti-inflammatory drugs or other forms of chemotherapy before their diagnosis;
• participants whose follow-up was interrupted three months ago without reaching any endpoint.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	OS is the time from initial diagnosis to death, or the last follow-up	From January 2018 to December 2024

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS)	PFS is the time from initial diagnosis to disease progression.	Form January 2018 to December 2024

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Nanchang University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): December 30, 2024
• Study Completion (Actual): April 21, 2025

Study Registration Dates

• First Submitted: July 25, 2025
• First Submitted That Met QC Criteria: November 16, 2025
• First Posted (Actual): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 16, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: O-[2025](65)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO