Back to resultsMultimodal Model for Efficacy Prediction Cetuximab in Colorectal Cancer Liver Metastasis Patient
Primary Purpose
Colorectal Cancer Liver Metastases
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Cetuximab
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer Liver Metastases
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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; Uncontrolled hypertension, or unsatisfactory blood pressure control with ≥3 antihypertensive drugs;
Sites / Locations
- Zhongshan Hospital, Fudan University
- Zhongshan hosptial, Fudan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
ARM A
ARM B
Arm Description
Chemotherapy regimens are determined based on the clinical experience of specialists
Chemotherapy regimens are determined based on the multimodal deep learning signature
Outcomes
Primary Outcome Measures
response rate
response rate will be assessed by local MDT
Secondary Outcome Measures
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
overall survival
overall survival will be assessed by researchers every two months during treatment, and telephone follow-up every three month after treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05873972
Brief Title
Multimodal Model for Efficacy Prediction Cetuximab in Colorectal Cancer Liver Metastasis Patient
Official Title
Multimodal Deep Learning Radiomic Nomogram for Evaluation of Response to Cetuximab in Patient With Colorectal Cancer Liver Metastasis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer Liver Metastases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ARM A
Arm Type
Active Comparator
Arm Description
Chemotherapy regimens are determined based on the clinical experience of specialists
Arm Title
ARM B
Arm Type
Experimental
Arm Description
Chemotherapy regimens are determined based on the multimodal deep learning signature
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Intervention Description
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
Primary Outcome Measure Information:
Title
response rate
Description
response rate will be assessed by local MDT
Time Frame
6 months
Secondary Outcome Measure Information:
Title
progression free survival
Description
progression free survival will be assessed by local MDT every two months during treatment, and telephone follow-up every three month after treatment
Time Frame
3 years
Title
overall survival
Description
overall survival will be assessed by researchers every two months during treatment, and telephone follow-up every three month after treatment
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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;
Uncontrolled hypertension, or unsatisfactory blood pressure control with ≥3 antihypertensive drugs;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianmin Xu, MD
Phone
+86-021-64041990
Email
xujmin@aliyun.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wenju Chang, MD
Phone
+86-021-64041990
Email
chang.wenju@zs-hospital.sh.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianmin Xu, MD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Zhongshan hosptial, Fudan University
City
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
Learn more about this trial
Multimodal Model for Efficacy Prediction Cetuximab in Colorectal Cancer Liver Metastasis Patient
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