Colorectal Cancer Liver MetastasesNCT05873972
Multimodal Model for Efficacy Prediction Cetuximab in Colorectal Cancer Liver Metastasis Patient
A study testing Cetuximab in people with Colorectal Cancer Liver Metastases, run by Fudan University at 2 sites in China.
Trial summary
Establishment and validation of the deep learning model of Cetuximab efficacy in simultaneous RAS wild unresectable CRLM patients Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer Liver Metastases
- What is being tested?
- Cetuximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jun 2023to 31 Dec 2024
- Phase
- Interventional
- 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
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 > 6 months;
- RAS and BRAF V600E wild-type;
- ECOG 0-1;
- Available CT imaging 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;
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- Second primary malignancy within the past 5 years;
- Drug or alcohol abuse;
- No legal capacity or limited legal capacity;
- Uncontrolled hypertension, or unsatisfactory blood pressure control with ≥3 antihypertensive drugs;
Trial locations and contacts
2 sites in 1 country.
China2 sites
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Zhongshan hosptial, Fudan University
Shanghai, 200032
About this study
Official title: Multimodal Deep Learning Radiomic Nomogram for Evaluation of Response to Cetuximab in Patient With Colorectal Cancer Liver Metastasis
Establishment and validation of the deep learning model of Cetuximab efficacy in simultaneous RAS wild unresectable CRLM patients
Read the detailed description
Ras wild unresectable CRLM patients with primary tumor resection followed by Cetuximab in combination with chemotherapy were included in this study. The tumor response was assessed by local MDT group. Based on tumor response, almost 100 CRLM patients were classified into two groups (Clinician drived regimen vs Multi-omics model drived regimen). They will be the prospective cohort to validate our deep learning model for predicting Cetuximab efficacy.
- Conditions
- Colorectal Cancer Liver Metastases
- Being tested
- Cetuximab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
AEM A：The specialist's decision to add cetuximab to chemotherapy will be based on their own judgment
ARM B：The patient's CT imaging,genetic mutation information were input into the signature, and the FOLFOX+cetuximab regimen was selected when the output label was 1. FOLFOX+bevacizumab chemotherapy regimen was selected when the output label was 0
| Study group | Role | What they receive |
|---|---|---|
| ARM A | Active comparator | Chemotherapy regimens are determined based on the clinical experience of specialists Receives: Drug: Cetuximab |
| ARM B | Experimental | Chemotherapy regimens are determined based on the multimodal deep learning signature Receives: Drug: Cetuximab |
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
Measured: 6 months
Secondary outcomes (2)
progression free survival
progression free survival will be assessed by local MDT every two months during treatment, and telephone follow-up every three month after treatment
Measured: 3 years
overall survival
overall survival will be assessed by researchers every two months during treatment, and telephone follow-up every three month after treatment
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer Liver MetastasesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
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
- NCT05873972
- Sponsor's protocol ID
- CRC-MULTIMODAL-02 RESEARCH
- Status last verified
- Jun 2022
- First submitted
- 17 Feb 2023
- Last updated
- 24 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Deep Learning Radiomic Nomogram for Evaluation of Response to Cetuximab in Patient With Colorectal Cancer Liver Metastasis
- ClinicalTrials.gov ID
- NCT05873972
- Acronym / sponsor ID
- CRC-MULTIMODAL-02 RESEARCH
- Conditions
- Colorectal Cancer Liver Metastases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 24 May 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.
Establishment and validation of the deep learning model of Cetuximab efficacy in simultaneous RAS wild unresectable CRLM patients
Detailed description
Ras wild unresectable CRLM patients with primary tumor resection followed by Cetuximab in combination with chemotherapy were included in this study. The tumor response was assessed by local MDT group. Based on tumor response, almost 100 CRLM patients were classified into two groups (Clinician drived regimen vs Multi-omics model drived regimen). They will be the prospective cohort to validate our deep learning model for predicting Cetuximab efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM A | Active comparator | Drug: CetuximabChemotherapy regimens are determined based on the clinical experience of specialists |
| ARM B | Experimental | Drug: CetuximabChemotherapy regimens are determined based on the multimodal deep learning signature |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 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 > 6 months;
Key exclusion criteria (10 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;
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 |
|---|---|---|
| CetuximabAEM A：The specialist's decision to add cetuximab to chemotherapy will be based on their own judgment ARM B：The patient's CT imaging,genetic mutation information were input into the signature, and the FOLFOX+cetuximab regimen was selected when the output label was 1. FOLFOX+bevacizumab 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
2 secondary outcomes
progression free survival
Time frame: 3 years
overall survival
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 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. This study is not recruiting at the moment.
Jianmin Xu, MD principal investigator
Fudan University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cetuximab in people with Colorectal Cancer Liver Metastases, run by Fudan University at 2 sites 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 8 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianmin Xu, MD (+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). 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 24 May 2023.