RecruitingPhase 3NCT05815082

ctDNA-guided Adjuvant Chemotherapy in Liver Metastasis of Colorectal Cancer

ctDNA-guided Adjuvant Chemotherapy in Liver Metastasis of Colorectal Cancer: A Prospective Multicenter Randomized Controlled Clinical Trial

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Enrollment

490 participants

Start Date

Feb 20, 2023

Study Type

INTERVENTIONAL

Conditions

Colorectal, Cancer Liver Metastases Circulating Tumor Cell Chemotherapy Effect

Summary

The goal of this clinical trial is to compare in resectable colorectal cancer liver metastasis patients.The main question it aims to answer is whether the 3-year progression-free survival rate (PFS) of "watching and waiting" is non-inferior to adjuvant chemotherapy in postoperative ctDNA-negative resectable colorectal cancer liver metastasis patients.Participants will undergo ctDNA testing after resection of colorectal cancer liver metastasis, and will be randomly assigned to receive adjuvant chemotherapy or "watching and waiting" treatment strategy. The researchers will compare the outcomes between the two groups to see if the PFS between the two groups is similar.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether using a blood test that detects tiny fragments of tumor DNA (called ctDNA) can help doctors decide whether colorectal cancer patients who have had liver surgery need additional chemotherapy. Researchers want to see if patients with no detectable cancer DNA in their blood after surgery can safely skip chemotherapy. **You may be eligible if...** - You are 18–75 years old - You have colorectal cancer that spread to the liver and had surgery to remove it completely (R0 resection) - You received chemotherapy before surgery - Your ctDNA blood test came back negative after surgery - You are in generally good health (ECOG score 0–2) **You may NOT be eligible if...** - Your cancer has spread to other areas like the pelvis, ovaries, or abdomen lining - You have had another type of cancer - You have serious problems with your liver, kidneys, heart, or lungs that prevent chemotherapy - You are pregnant or breastfeeding - You are allergic to any of the study drugs 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 cancer resection combined with liver metastasis resection.

The preferred surgical approach is resection of the corresponding colon segment with regional lymph node dissection. If conditions permit, synchronous resection of the primary lesion and liver metastases of colorectal cancer can be performed to achieve curative resection.

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.