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

Launched by SIXTH AFFILIATED HOSPITAL, SUN YAT-SEN UNIVERSITY · Apr 3, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help patients who have had surgery for liver metastases from colorectal cancer. Specifically, it wants to find out if taking a combination of chemotherapy and maintenance therapy after surgery can help patients live longer without their cancer getting worse, compared to just receiving chemotherapy alone. The trial focuses on patients who have had their cancer successfully removed during surgery and who still show signs of cancer in their blood, which is measured by a test called ctDNA.

To be eligible for this trial, participants must be between 18 and 75 years old and have had successful surgery for liver metastases from colorectal cancer. They should also have a specific test result indicating cancer presence in their blood. Patients with other active cancers, severe health issues, or certain allergies will not be able to participate. If you join this trial, you can expect close monitoring of your health and progress, and you will be contributing to important research that may improve treatment for future patients.

Gender

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Eligibility criteria

• 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.