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CompletedNCT07241403Updated Nov 21, 2025

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)

An observational study in Colorectal Cancer, Resistance and Bevacizimab, sponsored by Second Affiliated Hospital of Nanchang University. Completed at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-11-21.

Sponsored by Second Affiliated Hospital of Nanchang University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
698
Ages
18 Years to 85 Years
Sex
All
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Study summary

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.

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Conditions studied

  • Colorectal Cancer
  • Resistance
  • Bevacizimab
  • Inflamation
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In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 698 is above the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Second Affiliated Hospital of Nanchang University is the lead sponsor of 78 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
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.

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
698 participants (actual)
Target follow-up
36 Months
Patient registry
Yes
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What researchers measure

Primary outcomes

  1. Overall survival (OS)

    OS is the time from initial diagnosis to death, or the last follow-up

    Time frame: From January 2018 to December 2024

Secondary outcomes

  1. Progression-free survival (PFS)

    PFS is the time from initial diagnosis to disease progression.

    Time frame: Form January 2018 to December 2024

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Study locations

1 site
  • The second hospital of Nanchang university
    Nanchang, Jiangxi 330006, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07241403
Lead sponsor
Second Affiliated Hospital of Nanchang University
Responsible party
Sponsor
First posted
Nov 21, 2025
Start date
Jan 1, 2018
Primary completion
Dec 30, 2024
Completion
Apr 21, 2025
Last update
Nov 21, 2025

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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