Colorectal CancerNCT07241403
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 of Colorectal Cancer and Resistance, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colorectal Cancer, Resistance, Bevacizimab
- How many people
- 698 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 21 Apr 2025
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Clinical diagnosis of mCRC;
- Aged over 18 years;
- Must be able to receive the further treatment in the hospital.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
The second hospital of Nanchang university
Nanchang, Jiangxi, 330006
About this study
Official title: 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.
- Conditions
- Colorectal Cancer, Resistance, Bevacizimab, Inflamation
- Medical subject headings
- Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
OS is the time from initial diagnosis to death, or the last follow-up
Measured: From January 2018 to December 2024
Secondary outcomes (1)
Progression-free survival (PFS)
PFS is the time from initial diagnosis to disease progression.
Measured: Form January 2018 to December 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start1 Jan 2018
- Primary completion30 Dec 2024
- Study completion21 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Nanchang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 698 participants (actual)
- Target duration
- 36 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07241403
- Sponsor's protocol ID
- O-[2025](65)
- Status last verified
- May 2025
- First submitted
- 25 Jul 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Chronic Inflammation in Modulating Targeted Therapy Efficacy and Predicting Treatment Outcomes in Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07241403
- Acronym / sponsor ID
- O-[2025](65)
- Conditions
- Colorectal Cancer, Resistance, Bevacizimab, Inflamation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 698 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 21 Apr 2025 (actual)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Clinical diagnosis of mCRC;
- Aged over 18 years;
- Must be able to receive the further treatment in the hospital.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival (OS)
Time frame: From January 2018 to December 2024
OS is the time from initial diagnosis to death, or the last follow-up
1 secondary outcome
Progression-free survival (PFS)
Time frame: Form January 2018 to December 2024
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Resistance, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: From January 2018 to December 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025; AzTrials last refreshed its copy on 8 Nov 2026.