Thinking of joining a study?

Register your interest

Become a volunteer?

NCT05873972 | UNKNOWN | Colorectal Cancer Liver Metastases

Multimodal Model for Efficacy Prediction Cetuximab in Colorectal Cancer Liver Metastasis Patient
Sponsor:

Fudan University

Information provided by (Responsible Party):

X U Jianmin

Brief Summary:

Establishment and validation of the deep learning model of Cetuximab efficacy in simultaneous RAS wild unresectable CRLM patients

Condition or disease

Colorectal Cancer Liver Metastases

Intervention/treatment

Cetuximab

Phase

NA

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 Type : INTERVENTIONAL
Estimated Enrollment : 100 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Multimodal Deep Learning Radiomic Nomogram for Evaluation of Response to Cetuximab in Patient With Colorectal Cancer Liver Metastasis
Actual Study Start Date : 2023-06-01
Estimated Primary Completion Date : 2024-06-01
Estimated Study Completion Date : 2024-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Age 18-75 years;
  • 2. Histologically proven colorectal adenocarcinoma;
  • 3. Simultaneous liver-limited metastases;
  • 4. Initially unresectable liver metastases determined by a local MDT;
  • 5. Life expectancy of \> 6 months;
  • 6. RAS and BRAF V600E wild-type;
  • 7. ECOG 0-1;
  • 8. Available CT imaging before treatment.
Exclusion Criteria
  • 1. Previous systemic treatment for metastatic disease;
  • 2. Previous surgery for metastatic disease;
  • 3. Extrahepatic metastases;
  • 4. Unresectable primary tumor;
  • 5. Major cardiovascular events (myocardial infarction, severe/unstable angina, congestive heart failure, CVA) within 12 months before randomisation;
  • 6. Acute or subacute intestinal obstruction;
  • 7. Second primary malignancy within the past 5 years;
  • 8. Drug or alcohol abuse;
  • 9. No legal capacity or limited legal capacity;
  • 10. Uncontrolled hypertension, or unsatisfactory blood pressure control with ≥3 antihypertensive drugs;
Multimodal Model for Efficacy Prediction Cetuximab in Colorectal Cancer Liver Metastasis Patient

Location Details

NCT05873972

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

China, Shanghai

Z Hongshan Hospital, F U egg university

Shanghai, Shanghai, China, 200032

Not yet recruiting

China,

Z Sequoia Hosp Body Ali, F U Egg University

Shanghai, China, 200032