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Postoperation Maintenance Therapy for Resectable Liver Metastases of Colorectal Cancer Guided by ctDNA | Clinical Trials | Clareo Health

RECRUITINGPHASE3

Postoperation Maintenance Therapy for Resectable Liver Metastases of Colorectal Cancer Guided by ctDNA

Postoperation Maintenance Therapy for Resectable Liver Metastases of Colorectal Cancer Guided by ctDNA: a Multicenter, Randomized, Controlled, Phase III Clinical Trial.

NCT05797077•Sixth Affiliated Hospital, Sun Yat-sen University

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to compare in resectable liver metastases colorectal cancer patients.The main question it aims to answer is to investigate whether the progression-free survival (PFS) of resectable colorectal liver metastasis (CRLM) patients with positive ctDNA after surgery is superior with the combination of adjuvant chemotherapy and maintenance therapy compared to adjuvant chemotherapy alone.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Both males and females, aged 18-75 years;
•2. Patients with liver metastatic colorectal cancer who have undergone R0 resection based on MDT evaluation (including patients whose metastases have been treated with ablation achieving similar R0 resection effect);
•3. Postoperative ctDNA-positive patients;
•4. ASA grade \< IV and/or ECOG performance status score ≤ 2;
•5. Participants must have a full understanding of the study and voluntarily sign an informed consent form.

Exclusion Criteria

•1. Patients with distant metastases to other sites, including the pelvis, ovaries, peritoneum, etc.
•2. Patients with a history of other malignant tumors.
•3. Patients with severe liver or kidney dysfunction, cardiorespiratory dysfunction, coagulation dysfunction, or underlying diseases that cannot tolerate chemotherapy.
•4. Patients who are allergic to any component of the study.
•5. Patients who have received other tumor-related investigational drug treatments.
•6. Patients with severe uncontrolled recurrent infections or other severe uncontrolled accompanying diseases.
•7. Patients with other factors that may affect the study results or lead to early termination of the study, such as alcoholism, drug abuse, other serious diseases requiring comprehensive treatment (including mental illness), and severe laboratory abnormalities.
•8. Patients with a history of severe mental illness.
•9. Pregnant or lactating women.
•10. Patients who, in the opinion of the researchers, have other clinical or laboratory conditions that make them unsuitable for participation in the study.

Locations (1)

The Sixth Affiliate Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Key Dates

Start Date

February 20, 2023

Primary Completion Date

February 20, 2029

Completion Date

February 20, 2031

Last Updated

April 4, 2023

Enrollment

346

ESTIMATED participants

Conditions

Colorectal CancerLiver MetastasesCirculating Tumor CellCancer, Therapy-Related

Interventions

Colorectal resection surgery.

PROCEDURE

FOLFOX chemotherapy regimen

DRUG

Capecitabine

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 4, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Postoperation Maintenance Therapy for Resectable Liver Metastases of Colorectal Cancer Guided by ctDNA

Inclusion Criteria

Exclusion Criteria

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Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients w/ Metastatic Colorectal Cancer w/Liver Dominant Disease