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NCT Number: NCT05354674

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

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

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Key information

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Bevacizumab

Drug

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

Primary outcomes

  1. response rate

    Time frame: 6 months

    response rate will be assessed by local MDT every two months

  2. progression free survival

    Time frame: 3 years

    progression free survival will be assessed by local MDT every two months during

Secondary outcomes

  1. overall survival

    Time frame: 5 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jianmin Xu, Dr.

CONTACT

[email protected]

+86-021-64041990

Wenju Chang, Dr.

CONTACT

[email protected]

+86-021-64041990

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2028
First posted
Apr 29, 2022
Registry last updated
Jul 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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