CtDNA-Directed Post-Hepatectomy Chemotherapy for Patients with Resectable Colorectal Liver Metastases

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05062317

Patient View

This trial evaluates ctDNA's role in stratifying post-hepatectomy chemotherapy for colorectal liver metastases. It examines recurrence-free and overall survival, ctDNA sensitivity, and treatment changes. Eligible patients are adults undergoing elective hepatectomy after ≥4 cycles of preoperative chemotherapy. Interventions include Leucovorin, 5-FU, Oxaliplatin, Irinotecan, Capecitabine, and Bevacizumab.

Patient Parameters

Program 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.

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

Eligibility 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

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