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Clinical Trial 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.

Clinical Trial Description

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 ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05062317
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Timothy Newhook
Phone (713) 794-1001
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date March 30, 2022
Completion date February 28, 2026

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