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ctDNA-Directed Chemotherapy for Colorectal Liver Metastases

This study is looking at how to best treat colorectal cancer that has spread to the liver (colorectal liver metastases or CLM) after surgery. Researchers want to see if using a blood test for circulating tumor DNA (ctDNA) can help decide who needs more chemotherapy after their liver surgery. The study will use common chemotherapy drugs like Leucovorin, 5-FLUOROURACIL, Oxaliplatin, Irinotecan, and Capecitabine. You might be able to join if you are at least 18 years old, have CLM, are having liver surgery with the goal of cure, and have already received at least 4 cycles of chemotherapy before your surgery. The main goal is to see how many patients are free of cancer recurrence one year after surgery, especially those who are ctDNA-negative and receive chemotherapy based on their risk.

Study design
This is an interventional study planning to enroll 120 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed through study completion, which is an average of one year, to assess recurrence-free survival.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05062317

ctDNA-Directed Post-Hepatectomy Chemotherapy for Patients With Resectable Colorectal Liver Metastases

Recruiting
PHASE2Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~120 participants
Updated 2026-07-14 on ClinicalTrials.gov
What's tested:Leucovorin5-FLUOROURACILOxaliplatinIrinotecanCapecitabineBevacizumab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To establish the 1-year recurrence-free survival rate following liver resection of CLM with curative intent among ctDNA-negative patients who receive risk-stratified postoperative chemotherapy
Measured over through study completion, an average of 1 year

Conditions

Liver Metastases

Explore related trials

Colorectal CarcinomaMetastatic Malignant Neoplasm in the Liver

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Timothy Newhook · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Timothy Newhook
[email protected]
(713) 794-1001
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patients ≥18 years of age with CLM undergoing elective hepatectomy with curative intent (primary colorectal primary cancer previously removed OR being removed at time of hepatectomy) after preoperative chemotherapy (i.e., FOLFOX/FOLFIRI +/- bevacizumab or panitumumab/cetuximab) from 07/01/2021 - 12/31/2023
Must receive ≥ 4 cycles of preoperative chemotherapy

Exclusion

Patients with primary colorectal tumor that will remain in situ
Inability to undergo postoperative chemotherapy, or postoperative chemotherapy not planned a priori
Unwilling/unable to undergo blood draws for ctDNA, patient or provider-determined
Other active malignancies requiring treatment
Women who are pregnant

What this trial measures

  • To establish the 1-year recurrence-free survival rate following liver resection of CLM with curative intent among ctDNA-negative patients who receive risk-stratified postoperative chemotherapythrough study completion, an average of 1 year