RecruitingPhase 2NCT05062317

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

Risk-Stratified Adjuvant Therapy: ctDNA-Directed Post-Hepatectomy Chemotherapy for Patients With Resectable Colorectal Liver Metastases

Sponsor

M.D. Anderson Cancer Center

Enrollment

120 participants

Start Date

Apr 26, 2022

Study Type

INTERVENTIONAL

Conditions

Liver Metastases

Summary

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

Min Age: 18 Years

Inclusion Criteria2

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 Criteria5

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

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