Precision Medicine for Colorectal Cancer Liver Metastasis Guided by Multi-omics Data Under the Umbrella Theory

Colorectal Cancer Metastatic Clinical Trial

Official title:

Precision Medicine for Colorectal Cancer Liver Metastasis Guided by Multi-omics Data Under the Umbrella Theory

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04525807
• Other study ID #: 2020-08
• Status: Not yet recruiting
• Start date: September 1, 2020
• Est. completion date: September 1, 2022

Study information

• Verified date: August 2020
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In order to more accurately discover the cause of drug resistance in tumor treatment, and to provide a new basis for precise treatment.

Therefore, based on the umbrella theory of precision medicine, we carried out this single-center, prospective, and observational study to include patients with liver metastases from colorectal cancer. By combining genome, transcriptome, and proteomic sequencing data, we established a basis for colorectal cancer liver Transfer the multi-omics data of the sample, describe the reason for the resistance of the first-line treatment, and search for new therapeutic targets.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• ECOG score 0-2 points

• Pathologically diagnosed patients with colorectal cancer

• Combined with liver metastases confirmed by imaging, and the lesion is measurable (RECIST standard)

• The lesion is available

• First-line treatment failed; hematology, liver and kidney function tests are suitable for back-line treatment

• Informed consent

Exclusion Criteria:

• With brain metastases

• History of other malignancies

• Pregnancy or breastfeeding

• Have received other drug clinical studies within 30 days before the start of this study

Related Conditions & MeSH terms

• Colorectal Cancer Metastatic
• Colorectal Neoplasms

Intervention

Diagnostic Test:
• Multi-omics
Use multi-omics to analyze

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate	Refers to the proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time, including complete remission (CR) and partial remission (PR) cases	1 year
Secondary	progression-free survival	Refers to the date from initial diagnosis to tumor progression	1 year
Secondary	Overall survival	Refers to the date from initial diagnosis to last follow-up or death date	3 years