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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)

N

Nanchang University

Status

Completed

Conditions

Inflamation
Bevacizimab
Resistance
Colorectal Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT07241403
O-[2025](65)

Details and patient eligibility

About

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.

Enrollment

698 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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