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

Sponsor
Fudan University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05354674
Collaborator
(none)
20
1
6.6
3

Study Details

Study Description

Brief Summary

Establishment and validation of the deep learning model of bevacizumab efficacy in simultaneous RAS mutant unresectable CRLM patients

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Ras mutant unresectable CRLM patients with primary tumor resection followed by bevacizumab in combination with chemotherapy were included in this study. The tumor response was assessed by local MDT group. Based on tumor response, almost 20 CRLM patients were classified into two groups (CR+PR vs SD+PD). They will be the external cohort to validate our deep learning model for predicting bevacizumab efficacy.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Multimodal Deep Learning Radiomic Nomogram for Evaluation of Response to Bevacizumab in Patient With Colorectal Cancer Liver Metastasis
    Anticipated Study Start Date :
    Jun 15, 2022
    Anticipated Primary Completion Date :
    Jan 1, 2023
    Anticipated Study Completion Date :
    Jan 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    External Validation Cohort

    Outcome Measures

    Primary Outcome Measures

    1. response rate [6 months]

      response rate will be assessed by local MDT every two months

    Secondary Outcome Measures

    1. overall survival [3 years]

      overall survival will be assessed by researchers every two months during treatment, and telephone follow-up every three month after treatment

    Other Outcome Measures

    1. progression free survival [3 years]

      progression free survival will be assessed by local MDT every two months during treatment, and telephone follow-up every three month after treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 79 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    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;

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhongshan hospital Shanghai Shanghai China 200032

    Sponsors and Collaborators

    • Fudan University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xu jianmin, Head of Colorectal Surgery, Fudan University
    ClinicalTrials.gov Identifier:
    NCT05354674
    Other Study ID Numbers:
    • CRC-MULTIMODAL-01 RESEARCH
    First Posted:
    Apr 29, 2022
    Last Update Posted:
    Apr 29, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Xu jianmin, Head of Colorectal Surgery, Fudan University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 29, 2022