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

ConditionLiver Metastases

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorM.D. Anderson Cancer Center

About this trial

To determine if the detection of ctDNA after surgical resection of CLM can stratify patients into high and low-risk cohorts for early disease recurrence in order to inform post-operative adjuvant therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

Leucovorin
Drug
Given by PO
5-FLUOROURACIL
Drug
Given by IV
Oxaliplatin
Drug
Given by PO
Irinotecan
Drug
Given by IV
Capecitabine
Drug
Given by IV
Bevacizumab
Drug
Given by IV

Treatment groups

120 Participants

are divided into 2 treatment groups

Group A: ctDNA (Low Risk)Experimental treatment 2 interventions

Group B: ctDNA (High Risk)Experimental treatment 6 interventions

Trial outcomes

Primary outcomes

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

Time frame

through study completion, an average of 1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

Source ClinicalTrials.gov

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