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

• Conditions: Colorectal Cancer Metastatic
• Interventions: Diagnostic Test: Multi-omics

• Registration Number: NCT04525807
• Lead Sponsor: Fudan University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-21
• Study First Submitted QC: 2020-08-24
• Last Update Submitted: 2020-08-24
• Study First Posted: 2020-08-25
• Last Update Posted: 2020-08-25
• Study Start: 2020-09-01
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Multiomics arm	Multi-omics	Guide therapy based on multi-omics

Primary Outcome Measures

Name	Time	Method
Objective response rate	1 year	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

Secondary Outcome Measures

Name	Time	Method
progression-free survival	1 year	Refers to the date from initial diagnosis to tumor progression
Overall survival	3 years	Refers to the date from initial diagnosis to last follow-up or death date