The Patients With CRLM Who Benefit More From BevacizumabNCT06023173
Deep Radiomics-based Fusion Model Predicting Bevacizumab Treatment Response and Outcome in Patients With Colorectal Liver Metastases
An observational study of The Patients With CRLM Who Benefit More From Bevacizumab, run by Fudan University at 1 site in China.
Trial summary
This multi-modal deep radiomics model, using PET/CT, clinical and histopathological data, was able to identify patients with bevacizumab-sensitive unresectable colorectal cancer liver metastases, providing a favorable approach for precise patient treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- The Patients With CRLM Who Benefit More From Bevacizumab
- What is being tested?
- Deep radiomics-based fusion model
- How many people
- 307 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2013to 1 Jan 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In this multicenter cohort study, the investigators collected 307 patients with colorectal cancer liver metastases. The training cohort and negative validation cohort were derived from the BECOME study (NCT01972490), for whom baseline PET/CT images were available. The internal validation cohort was derived from consecutive metastastic colorectal cancer patients of the multi-disciplinary team (MDT) at Zhongshan Hospital (ZSH), share the same MDT, surgical team, and PET/CT imaging equipment with training cohort, from 01 January 2018 to 31 December 2018. The external validation cohort came from the MDT of Zhongshan Hospital - Xiamen and the First Hospital of Wenzhou Medical University, from 01 January 2020 to 31 December 2020
Who may be able to join
- Age ≥ 18 years and ≤75 years;
- Patients were histologically confirmed for colorectal adenocarcinoma with unresectable liver-limited or liver-dominant metastases
- PET/CT at baseline were available
- First line treated with FOLFOX+ bevacizumab.
Who cannot join
- Resectable liver metastases;
- Wide-type KRAS/NRAS;
- No measurable liver metastasis;
- No efficacy assessment;
- No follow-up information.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of General Surgery, Zhongshan Hospital, Fudan University
Shanghai
About this study
Official title: Deep Radiomics-based Fusion Model Predicting Bevacizumab Treatment Response and Outcome in Patients With Colorectal Liver Metastases: a Multicenter Cohort Study
This multi-modal deep radiomics model, using PET/CT, clinical and histopathological data, was able to identify patients with bevacizumab-sensitive unresectable colorectal cancer liver metastases, providing a favorable approach for precise patient treatment.
Read the detailed description
Accurately predicting tumor response to targeted therapies is essential for guiding personalized conversion therapy in patients with unresectable colorectal cancer liver metastases (CRLM). Currently, tumor response evaluation criteria are based on assessments made after at least 2-months treatment. Consequently, there is a compelling need to develop baseline tools that can be used to guide therapy selection. Herein, the investigators proposed a deep radiomics-based fusion model which demonstrates high accuracy in predicting the efficacy of bevacizumab in CRLM patients. Further, the investigators observed a significant and positive association between the predicted-responders and longer progression-free survival as well as longer overall survival in CRLM patients treated with bevacizumab. Moreover, the model exhibits high negative prediction value, indicating its potential to accurately identify individuals who are unresponsive to bevacizumab. Thus, our model provides a valuable baseline method for specifically identifying bevacizumab-sensitive CRLM patients, which is offering a clinically convenient approach to guide precise patient treatment.
- Being tested
- Deep radiomics-based fusion model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep radiomics-based fusion modelDiagnostic test
Also called deep learning model
This multi-modal deep radiomics model, using PET/CT, clinical and histopathological data, was able to identify patients with bevacizumab-sensitive CRLM, providing a favorable approach for precise patient treatment.
| Study group | Role | What they receive |
|---|---|---|
| Training Cohort | This cohort was derived from Arm A (treated with FOLFOX + bevacizumab) of the BECOME studyand was used for model construction. Receives: Diagnostic Test: Deep radiomics-based fusion model | |
| Negative Validation Cohort | The cohort was derived from Arm B (treated with FOLFOX) of the BECOME study , which demonstrated that the model specifically predicted the efficacy of bevacizumab. Receives: Diagnostic Test: Deep radiomics-based fusion model | |
| Internal Validation Cohort | The cohort was derived from an independent Zhongshan Hospital cohort with the same treatment team and imaging instrumentation as the BECOME study, differing only in patient period, and was used for internal validation of the model. Receives: Diagnostic Test: Deep radiomics-based fusion model | |
| External Validation Cohort | The cohort was obtained from the Zhongshan Hospital - Xiamenand the First Affiliated Hospital of Wenzhou Medical University for external validation of the model. Receives: Diagnostic Test: Deep radiomics-based fusion model |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective response rate of patients with colorectal cancer liver metastases who treated with FOLFOX+bevacizumab/FOLFOX
Measured: 2013.10.1-2023.1.1
PFS
Progression-free survival of patients with colorectal cancer liver metastases who treated with FOLFOX+bevacizumab/FOLFOX
Measured: 2013.10.1-2023.1.1
Secondary outcomes (1)
OS
Overall survival of patients with colorectal cancer liver metastases who treated with FOLFOX+bevacizumab/FOLFOX
Measured: 2013.10.1-2023.1.1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start1 Oct 2013
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Patients With CRLM Who Benefit More From BevacizumabStudies of the same condition, open and under way.
- More trials run by Fudan 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
- Retrospective
- Enrolment
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu jianmin, Fudan University
- Investigators
- Jianmin Xu, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023173
- Sponsor's protocol ID
- DERBY
- Status last verified
- Aug 2023
- First submitted
- 29 Aug 2023
- Last updated
- 14 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Radiomics-based Fusion Model Predicting Bevacizumab Treatment Response and Outcome in Patients With Colorectal Liver Metastases: a Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT06023173
- Acronym / sponsor ID
- DERBY
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Oct 2013 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 5 Sep 2023 (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.
This multi-modal deep radiomics model, using PET/CT, clinical and histopathological data, was able to identify patients with bevacizumab-sensitive unresectable colorectal cancer liver metastases, providing a favorable approach for precise patient treatment.
Detailed description
Accurately predicting tumor response to targeted therapies is essential for guiding personalized conversion therapy in patients with unresectable colorectal cancer liver metastases (CRLM). Currently, tumor response evaluation criteria are based on assessments made after at least 2-months treatment. Consequently, there is a compelling need to develop baseline tools that can be used to guide therapy selection. Herein, the investigators proposed a deep radiomics-based fusion model which demonstrates high accuracy in predicting the efficacy of bevacizumab in CRLM patients. Further, the investigators observed a significant and positive association between the predicted-responders and longer progression-free survival as well as longer overall survival in CRLM patients treated with bevacizumab. Moreover, the model exhibits high negative prediction value, indicating its potential to accurately identify individuals who are unresponsive to bevacizumab. Thus, our model provides a valuable baseline method for specifically identifying bevacizumab-sensitive CRLM patients, which is offering a clinically convenient approach to guide precise patient treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Training Cohort | – | Diagnostic Test: Deep radiomics-based fusion modelThis cohort was derived from Arm A (treated with FOLFOX + bevacizumab) of the BECOME studyand was used for model construction. |
| Negative Validation Cohort | – | Diagnostic Test: Deep radiomics-based fusion modelThe cohort was derived from Arm B (treated with FOLFOX) of the BECOME study , which demonstrated that the model specifically predicted the efficacy of bevacizumab. |
| Internal Validation Cohort | – | Diagnostic Test: Deep radiomics-based fusion modelThe cohort was derived from an independent Zhongshan Hospital cohort with the same treatment team and imaging instrumentation as the BECOME study, differing only in patient period, and was used for internal validation of the model. |
| External Validation Cohort | – | Diagnostic Test: Deep radiomics-based fusion modelThe cohort was obtained from the Zhongshan Hospital - Xiamenand the First Affiliated Hospital of Wenzhou Medical University for external validation of the model. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In this multicenter cohort study, the investigators collected 307 patients with colorectal cancer liver metastases. The training cohort and negative validation cohort were derived from the BECOME study (NCT01972490), for whom baseline PET/CT images were available. The internal validation cohort was derived from consecutive metastastic colorectal cancer patients of the multi-disciplinary team (MDT) at Zhongshan Hospital (ZSH), share the same MDT, surgical team, and PET/CT imaging equipment with training cohort, from 01 January 2018 to 31 December 2018. The external validation cohort came from the MDT of Zhongshan Hospital - Xiamen and the First Hospital of Wenzhou Medical University, from 01 January 2020 to 31 December 2020
Key inclusion criteria (4 listed)
- Age ≥ 18 years and ≤75 years;
- Patients were histologically confirmed for colorectal adenocarcinoma with unresectable liver-limited or liver-dominant metastases
- PET/CT at baseline were available
- First line treated with FOLFOX+ bevacizumab.
Key exclusion criteria (5 listed)
- Resectable liver metastases;
- Wide-type KRAS/NRAS;
- No measurable liver metastasis;
- No efficacy assessment;
- No follow-up information.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep radiomics-based fusion modelAlso: deep learning modelThis multi-modal deep radiomics model, using PET/CT, clinical and histopathological data, was able to identify patients with bevacizumab-sensitive CRLM, providing a favorable approach for precise patient treatment. | Diagnostic test | External Validation Cohort, Internal Validation Cohort, Negative Validation Cohort, Training Cohort |
Primary outcome
ORR
Time frame: 2013.10.1-2023.1.1
Objective response rate of patients with colorectal cancer liver metastases who treated with FOLFOX+bevacizumab/FOLFOX
PFS
Time frame: 2013.10.1-2023.1.1
Progression-free survival of patients with colorectal cancer liver metastases who treated with FOLFOX+bevacizumab/FOLFOX
1 secondary outcome
OS
Time frame: 2013.10.1-2023.1.1
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 14 Sep 2023.
- Individual participant dataSharing planned: No
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.
Jianmin Xu, MD principal investigator
Fudan University
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 The Patients With CRLM Who Benefit More From Bevacizumab, run by Fudan 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 4 inclusion and 5 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 14 Sep 2023. 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?
ORR (time frame: 2013.10.1-2023.1.1). The study lists 2 primary outcomes in all. 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 14 Sep 2023.