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

Overview

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.

Primary Objective: • To assess 1-year recurrence-free survival rate following liver resection of CLM with curative intent among ctDNA-negative patients who receive risk-stratified postoperative chemotherapy Secondary Objectives: * To assess recurrence-free survival following liver resection of CLM with curative intent among ctDNA-positive patients * To assess overall survival following liver resection among ctDNA-negative and ctDNA-positive patients * To evaluate the proportion of ctDNA-negative at 1-year post-resection * To compare survival of ctDNA-negative patients undergoing ctDNA-guided postoperative chemotherapy to historical controls * To evaluate proportion of patients in each arm who change chemotherapy in response to ctDNA measurement * To delineate the pattern of disease recurrence * To assess ctDNA sensitivity and specificity for predicting disease recurrence * To evaluate MDASI-GI during the course of postoperative therapy * To evaluate and correlate patient molecular subtypes and characterization of tumor biologic factors that are associated with ctDNA detection * To evaluate surgery-related adverse events occurring up to 90 days after surgery, and chemo-related adverse events occurring up to 30 days after the last dose of chemotherapy Outcome Measures: Primary: • Recurrence-free survival at 1-year post-hepatectomy among ctDNA-negative patients Secondary: * Recurrence-free survival at 1-year post-hepatectomy among ctDNA-positive patients * Overall survival (OS) among ctDNA-negative and ctDNA-positive patients * ctDNA-negativity at 1-year post-resection * Proportion of patients in each group with chemotherapy regimen change in response to ctDNA dynamics * Pattern of disease recurrence (i.e., liver, systemic, salvageable vs. unsalvageable) * ctDNA sensitivity/specificity for recurrent disease overall by timepoint * MDASI-GI at clinic visits during course of postoperative therapy * Tumor radiologic, histologic, and molecular profiling and correlative characterization based upon ctDNA detection * Adverse events

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Eligibility

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Outcomes

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