RecruitingPhase 3NCT05797077

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

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

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Enrollment

346 participants

Start Date

Feb 20, 2023

Study Type

INTERVENTIONAL

Conditions

Colorectal, Cancer Liver Metastases Circulating Tumor Cell Cancer, Therapy-Related

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is using a blood-based cancer DNA test (called ctDNA) to guide maintenance chemotherapy after liver surgery in patients with colorectal cancer that has spread to the liver. The idea is that detectable cancer DNA in the blood after surgery signals a higher risk of cancer coming back. **You may be eligible if...** - You are between 18 and 75 years old - You have colorectal cancer with liver spread (liver metastases) and have had an R0 resection (surgery that removed all visible cancer) - Your blood test after surgery showed detectable cancer DNA (ctDNA-positive) - You have a good performance status (ECOG score of 2 or less) - You have signed informed consent **You may NOT be eligible if...** - Your post-surgery ctDNA test is negative - You have had other cancers - Other organ function or health criteria are not met Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREColorectal resection surgery.

Colorectal cancer radical resection combined with liver metastasis resection or ablation.

DRUGFOLFOX chemotherapy regimen

Chemotherapy regimens recommended include oxaliplatin-based CapeOx or FOLFOX regimens, or single-agent 5-FU/LV, capecitabine, or combination with targeted therapy.

DRUGCapecitabine

Maintenance therapy is recommended to be continued with low-toxicity drugs such as 5-FU/LV or capecitabine, and may be combined with targeted therapy. Treatment should be discontinued once ctDNA testing is negative.