Radiomics Assess of Bevacizumab Plus Chemo in Colorectal Cancer Liver Metastases (ROBOT)

August 10, 2020 updated by: Peking University People's Hospital

A Radiomics Approach to Predict the Effect of Bevacizumab Plus Chemotherapy in Patients With Liver Metastases of Colorectal Cancer: A Prospective Multi-Centers Trial

Colorectal carcinoma with liver metastasis is one of the major problems bothering physicians worldwide. Bevacizumab combined with chemotherapy is the standard treatment recommended by several guidelines. Despite the high cost, a certain portion of patients couldn't benefit from this therapy. This study is aiming to find out the specific type of patients who would respond to bevacizumab by Radiomics approach, and evaluate the prediction value of this imaging model with clinical and genetic factors.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Peking, Beijing, China, 100044

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients of colorectal carcinoma with liver metastasis

Description

Inclusion Criteria:

  1. Colorectal carcinoma confirmed by pathological result.
  2. Liver metastasis confirmed by imaging studies.
  3. Treatment of bevacizumab combined with chemotherapy chosen by MDT team.
  4. ECOG: 0-2.
  5. Normal laboratory studies including liver\renal\bone marrow functions.
  6. Expected lifespan more than 3 months.

Exclusion Criteria:

  1. Previous treatment of colorectal cancer with liver metastasis.
  2. Diagnosed with other malignancies.
  3. Couldn't finish the trial due to several reasons such as allergy to chemotherapy drugs\pregnancy or lactation\chronic heart disease\unable to sustain further treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
estimated ORR
Time Frame: 6-8 weeks
6-8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
estimated PFS
Time Frame: 3 years
3 years
estimated OS
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2020

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

December 25, 2019

First Submitted That Met QC Criteria

December 25, 2019

First Posted (Actual)

December 30, 2019

Study Record Updates

Last Update Posted (Actual)

August 11, 2020

Last Update Submitted That Met QC Criteria

August 10, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20181113

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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