Radiomics Assess of Bevacizumab Plus Chemo in Colorectal Cancer Liver Metastases

NCT04213222 | Unknown FDA Drug

• 1 other identifier: 20181113
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colon Cancer; Rectal Cancer; Liver Metastases

Keywords

colorectal cancer; liver metastasis; bevacizumab

Outcome Measures

Primary Outcomes (1)

• estimated ORR

  6-8 weeks

Secondary Outcomes (2)

• estimated PFS

  3 years

• estimated OS

  3 years

Interventions

Bevacizumab DRUG

bevacizumab combined with chemotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of colorectal carcinoma with liver metastasis

You may qualify if:

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

You may not qualify if:

• Previous treatment of colorectal cancer with liver metastasis.
• Diagnosed with other malignancies.
• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms; Colorectal Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Yudi Bao, MD

CONTACT

8613810355879; ggpptang@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2019
• First Posted: December 30, 2019
• Study Start: October 1, 2020
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2023
• Last Updated: August 11, 2020

Record last verified: 2020-08

Locations

CN (1)