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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSixth Affiliated Hospital, Sun Yat-sen University

About this trial

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 criteria

Qualifiers

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;

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Colorectal resection surgery.
  • FOLFOX chemotherapy regimen
  • Capecitabine

Treatment groups

346 Participants
are divided into 2 treatment groups