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

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

Treatments tested in this trial

  • Leucovorin
  • 5-FLUOROURACIL
  • Oxaliplatin
  • Irinotecan
  • Capecitabine
  • Bevacizumab

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators