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

Recruiting now · Phase 3

Conditions studied: Colorectal Cancer, Liver Metastases, Circulating Tumor Cell, Cancer, Therapy-Related

In brief

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.

Key facts

Study ID

NCT05797077

Run by

Sixth Affiliated Hospital, Sun Yat-sen University

People needed

346

Starts

2023-02-20

Expected to finish

2031-02-20

Last updated by the study team

2023-04-04

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Both males and females, aged 18-75 years;
• 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);
• Postoperative ctDNA-positive patients;
• ASA grade < IV and/or ECOG performance status score ≤ 2;
• Participants must have a full understanding of the study and voluntarily sign an informed consent form.

You may not qualify if…

• Patients with distant metastases to other sites, including the pelvis, ovaries, peritoneum, etc.
• Patients with a history of other malignant tumors.
• Patients with severe liver or kidney dysfunction, cardiorespiratory dysfunction, coagulation dysfunction, or underlying diseases that cannot tolerate chemotherapy.
• Patients who are allergic to any component of the study.
• Patients who have received other tumor-related investigational drug treatments.
• Patients with severe uncontrolled recurrent infections or other severe uncontrolled accompanying diseases.
• 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.
• Patients with a history of severe mental illness.
• Pregnant or lactating women.
• Patients who, in the opinion of the researchers, have other clinical or laboratory conditions that make them unsuitable for participation in the study.

Where it is running

• The Sixth Affiliate Hospital of Sun Yat-Sen University — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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