Post-Surgery Chemotherapy Guided by ctDNA Testing for Patients With Resectable Colorectal Liver Metastases

What this Trial Is About

Researchers are evaluating if detecting circulating tumor DNA ctDNA after surgical removal of colorectal liver metastases CLM can help sort patients into high or low-risk groups for early cancer return. This study focuses on patients who have undergone liver resection with the goal of curing CLM and aims to guide post-surgery chemotherapy based on ctDNA results. It is a Phase 2 interventional trial assessing survival outcomes and chemotherapy responses related to ctDNA status. Participants receive ctDNA-directed chemotherapy after surgery. Those testing ctDNA-negative receive less intense chemotherapy, such as capecitabine or 5-fluorouracil, while ctDNA-positive patients receive more intense chemotherapy, potentially resuming pre-surgery regimens like FOLFOX or FOLFIRI with or without bevacizumab. Treatments include several drugs given orally or intravenously, and therapy is risk-stratified to tailor postoperative care. During the study, participants undergo blood draws to measure ctDNA and receive follow-up assessments for recurrence-free survival, overall survival, chemotherapy changes, and adverse events related to surgery and chemotherapy. Researchers also evaluate tumor characteristics and patient-reported symptoms using MDASI-GI questionnaires. The primary outcome is recurrence-free survival at one year post-surgery in ctDNA-negative patients, with ongoing monitoring of disease patterns and treatment effects through the studys completion.

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