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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07241403

Enrollment

698

Registered

2025-11-21

Start date

2018-01-01

Completion date

2025-04-21

Last updated

2025-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bevacizimab, Colorectal Cancer, Inflamation, Resistance

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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.

Design outcomes

Primary

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

Secondary

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

Countries

China

Outcome results