Colorectal CancerNCT05354674
Multimodal Deep Learning Signature for Evaluation of Response to Bevacizumab in Patient With Colorectal Cancer Liver Metastasis
An observational study of Colorectal Cancer and Liver Metastases, run by Fudan University at 1 site in China.
Trial summary
Establishment and validation of the deep learning signature of bevacizumab efficacy in initially unresectable CRLM patients Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Colorectal Cancer, Liver Metastases
- What is being tested?
- Bevacizumab
- How many people
- 302 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 1 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Initially unresectable CRLM patients with PET/CT images and colonoscopy biopsy specimens before treatment.
Who may be able to join
- Age 18-75 years; Histologically proven colorectal adenocarcinoma; Simultaneous liver-limited metastases; Initially unresectable liver metastases determined by a local MDT; Life expectancy of > 3 months; RAS mutation and BRAF V600E wild-type; ECOG 0-1; Available PET/CT imaging before treatment; Available colonoscopy biopsy specimens before treatment
Who cannot join
- Previous systemic treatment for metastatic disease; Previous surgery for metastatic disease; Extrahepatic metastases; Unresectable primary tumor; Major cardiovascular events (myocardial infarction, severe/unstable angina, congestive heart failure, CVA) within 12 months before randomisation; Acute or subacute intestinal obstruction; Second primary malignancy within the past 5 years; Drug or alcohol abuse; No legal capacity or limited legal capacity; Pregnant or lactating women; Uncontrolled hypertension, or unsatisfactory blood pressure control with ≥3 antihypertensive drugs; Peripheral neuropathy;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongshan hospital
Shanghai, Shanghai Municipality, 200032
Jianmin Xu, Dr., +86-216-4041990, xujmin@aliyun.com
Wenju Chang, Dr., +86-216-4041990, chang.wenju@zs-hospital.sh.cn
About this study
Establishment and validation of the deep learning signature of bevacizumab efficacy in initially unresectable CRLM patients
Read the detailed description
Initially unresectable CRLM patients were included in this study. The tumor response was assessed by local MDT group. The signature will classified patients into responder or non-responder group. We will administer mFOLFOX6+bevacizumab regimen to responders, and FOLFOXIRI regimen to non-responders.
- Conditions
- Colorectal Cancer, Liver Metastases
- Being tested
- Bevacizumab
- Keywords
- colorectal cancer liver metastasis, bevacizumab, radiomics, multimodal
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
AEM A：The specialist's decision to add bevacizumab to chemotherapy will be based on their own judgment
ARM B：The patient's PET/CT imaging, pathology, and clinical information were input into the signature, and the FOLFOX+Bevacizumab regimen was selected when the output label was 1. FOLFOXIRI chemotherapy regimen was selected when the output label was 0
| Study group | Role | What they receive |
|---|---|---|
| ARM A | Chemotherapy regimens are determined based on the clinical experience of specialists Receives: Drug: Bevacizumab | |
| ARM B | Chemotherapy regimens are determined based on the multimodal deep learning signature Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate
response rate will be assessed by local MDT every two months
Measured: 6 months
progression free survival
progression free survival will be assessed by local MDT every two months during
Measured: 3 years
Secondary outcomes (1)
overall survival
overall survival will be assessed by researchers every two months during treatment, and telephone follow-up every three month after treatment
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start1 Sep 2023 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2028 (estimated)
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 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
- Prospective
- Enrolment
- 302 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu jianmin, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05354674
- Sponsor's protocol ID
- CRC-MULTIMODAL-01 RESEARCH
- Status last verified
- Jan 2023
- First submitted
- 26 Apr 2022
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Deep Learning Signature for Evaluation of Response to Bevacizumab in Patient With Colorectal Cancer Liver Metastasis
- ClinicalTrials.gov ID
- NCT05354674
- Acronym / sponsor ID
- CRC-MULTIMODAL-01 RESEARCH
- Conditions
- Colorectal Cancer, Liver Metastases
- Keywords
- colorectal cancer liver metastasis, bevacizumab, radiomics, multimodal
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 302 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 29 Apr 2022 (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.
Establishment and validation of the deep learning signature of bevacizumab efficacy in initially unresectable CRLM patients
Detailed description
Initially unresectable CRLM patients were included in this study. The tumor response was assessed by local MDT group. The signature will classified patients into responder or non-responder group. We will administer mFOLFOX6+bevacizumab regimen to responders, and FOLFOXIRI regimen to non-responders.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM A | – | Drug: BevacizumabChemotherapy regimens are determined based on the clinical experience of specialists |
| ARM B | – | Drug: BevacizumabChemotherapy regimens are determined based on the multimodal deep learning signature |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Initially unresectable CRLM patients with PET/CT images and colonoscopy biopsy specimens before treatment.
Key inclusion criteria (1 listed)
- Age 18-75 years; Histologically proven colorectal adenocarcinoma; Simultaneous liver-limited metastases; Initially unresectable liver metastases determined by a local MDT; Life expectancy of > 3 months; RAS mutation and BRAF V600E wild-type; ECOG 0-1; Available PET/CT imaging before treatment; Available colonoscopy biopsy specimens before treatment
Key exclusion criteria (1 listed)
- Previous systemic treatment for metastatic disease; Previous surgery for metastatic disease; Extrahepatic metastases; Unresectable primary tumor; Major cardiovascular events (myocardial infarction, severe/unstable angina, congestive heart failure, CVA) within 12 months before randomisation; Acute or subacute intestinal obstruction; Second primary malignancy within the past 5 years; Drug or alcohol abuse; No legal capacity or limited legal capacity; Pregnant or lactating women; Uncontrolled hypertension, or unsatisfactory blood pressure control with ≥3 antihypertensive drugs; Peripheral neuropathy;
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 |
|---|---|---|
| BevacizumabAEM A：The specialist's decision to add bevacizumab to chemotherapy will be based on their own judgment ARM B：The patient's PET/CT imaging, pathology, and clinical information were input into the signature, and the FOLFOX+Bevacizumab regimen was selected when the output label was 1. FOLFOXIRI chemotherapy regimen was selected when the output label was 0 | Drug | ARM A, ARM B |
Primary outcome
response rate
Time frame: 6 months
response rate will be assessed by local MDT every two months
progression free survival
Time frame: 3 years
progression free survival will be assessed by local MDT every two months during
1 secondary outcome
overall survival
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
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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.
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 Liver Metastases, 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 13 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianmin Xu, Dr. (+86-021-64041990, xujmin@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response rate (time frame: 6 months). 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 13 Jul 2023.