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

Sun Yat-sen University

Status and phase

Enrolling

Phase 3

Conditions

Liver Metastases

Circulating Tumor Cell

Cancer, Therapy-Related

Colorectal Cancer

Treatments

Drug: FOLFOX chemotherapy regimen

Drug: Capecitabine

Procedure: Colorectal resection surgery.

Study type

Interventional

Funder types

Other

Identifiers

NCT05797077

1010(PY)2022-10

Details and patient eligibility

About

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.

Enrollment

346 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.