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NCT04213222 Clinical Trial

Radiomics Assess of Bevacizumab Plus Chemo in Colorectal Cancer Liver Metastases

Rectal Cancer Clinical Trial

— ROBOT  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04213222
Other study ID # 20181113
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 2020
Est. completion date December 2023

Study information
Verified date August 2020
Source Peking University People's Hospital
Contact Yudi Bao, MD
Phone 8613810355879
Email ggpptang@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 300
Est. completion date December 2023
Est. primary completion date June 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Bevacizumab
bevacizumab combined with chemotherapy

Locations
Country Name City State
China Peking University People's Hospital Peking Beijing

Sponsors (1)
Lead Sponsor Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary estimated ORR 6-8 weeks
Secondary estimated PFS 3 years
Secondary estimated OS 3 years
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