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

• Status: Not yet recruiting
• Trial end date: 2026-02-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Bevacizumab; Capecitabine; Fluorouracil; Irinotecan; Leucovorin; Oxaliplatin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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