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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
The Sixth Affiliate Hospital of Sun Yat-Sen University
RECRUITING
Guangzhou
Time Frame
Start Date: 2023-02-20
Estimated Completion Date: 2031-02-20
Participants
Target number of participants: 346
Treatments
Experimental: Adjuvant chemotherapy combined with maintenance therapy
Sham_comparator: Single adjuvant chemotherapy
Related Therapeutic Areas
Sponsors
Leads: Sixth Affiliated Hospital, Sun Yat-sen University

This content was sourced from clinicaltrials.gov