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)

NCT ID: NCT07241403

Last Updated: 2025-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

698 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2025-04-21

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer Resistance Bevacizimab Inflamation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital of Nanchang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The second hospital of Nanchang university

Nanchang, Jiangxi, China

Site Status

Countries

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China

Other Identifiers

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O-[2025](65)

Identifier Type: -

Identifier Source: org_study_id

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