The Value of ctDNA on Chemotherapy Efficacy for mCRC

Not Applicable

Recruiting

• Conditions: Circulating Tumor DNA

• Registration Number: NCT04555369
• Lead Sponsor: Fudan University

Brief Summary

The study is designed to evaluate the value of ctDNA in predicting the drug efficacy of chemotherapy for metastatic colorectal cancer.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-09
• Study First Submitted: 2020-09-15
• Study First Submitted QC: 2020-09-15
• Study First Posted: 2020-09-18
• Study Start: 2020-09-23
• Last Update Submitted: 2021-07-13
• Last Update Posted: 2021-07-19
• Primary Completion: 2023-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

aged ≥18 years with histologically or cytologically confirmed advanced colorectal adenocarcinoma Eastern Cooperative Oncology Group performance status of 0 to 2 life expectancy of ≥ 3 months at least one measurable metastatic lesion have adequate bone marrow, hepatic, and renal function

Exclusion Criteria

patients with previous chronic inflammatory bowel disease, chronic diarrhea or recurrent bowel obstruction patients with symptomatic brain metastases active clinical severe infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Response rate	2 months	the response rate predicted by ct-DNA

Secondary Outcome Measures

Name	Time	Method
Overall survival	2 months
Progression free survival	2 months

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China