Multimodal Deep Learning Signature for Evaluation of Response to Bevacizumab in Patient With Colorectal Cancer Liver Metastasis

Colorectal Cancer Clinical Trial

Official title:

Multimodal Deep Learning Signature for Evaluation of Response to Bevacizumab in Patient With Colorectal Cancer Liver Metastasis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05354674
• Other study ID #: CRC-MULTIMODAL-01 RESEARCH
• Status: Not yet recruiting
• Start date: September 1, 2023
• Est. completion date: July 1, 2028

Study information

• Verified date: January 2023
• Source: Fudan University
• Contact: Jianmin Xu, Dr.
• Phone: +86-021-64041990
• Email: xujmin[@]aliyun.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Establishment and validation of the deep learning signature of bevacizumab efficacy in initially unresectable CRLM patients

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 302
• Est. completion date: July 1, 2028
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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 > 3 months; RAS mutation and BRAF V600E wild-type; ECOG 0-1; Available PET/CT imaging before treatment; Available colonoscopy biopsy specimens 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; Pregnant or lactating women; Uncontrolled hypertension, or unsatisfactory blood pressure control with =3 antihypertensive drugs; Peripheral neuropathy;

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Liver Metastases
• Liver Neoplasms
• Neoplasm Metastasis

Intervention

Drug:
• Bevacizumab
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

Locations

Country	Name	City	State
China	Zhongshan hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response rate	response rate will be assessed by local MDT every two months	6 months
Primary	progression free survival	progression free survival will be assessed by local MDT every two months during	3 years
Secondary	overall survival	overall survival will be assessed by researchers every two months during treatment, and telephone follow-up every three month after treatment	5 years